The Respond OC Conserving Regulator (130-0800) is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use. It may also be used to deliver a constant flow of oxygen to the patient.

Device Description

The Respond OC Conserving Regulator (130-0800) is a dual mode high pressure oxygen regulator and conserving device that allows for either a continuous or conserve flow of medical grade oxygen to the patient. The device is designed with a CGA 870 style yoke for use with ambulatory oxygen cylinders. The integrated regulator reduces cylinder pressure to 22psig (+/-3psi) to the sensing diaphragm which allows the Respond OC to sense the start of inhalation by the patient and release a controlled amount of oxygen by pneumatic timing in short bursts into the lungs via an oxygen cannula. The Respond OC supports a delivered oxygen equivalency of 1 to 5 LPM in the conserve mode, which extends the ambulatory time of cylinders up to 6:1 based on the cylinder pressure and selected setting. The continuous flow mode offers settings of 2, 3 and 4 LPM if the patient requires a constant flow of oxygen.

AI/ML Overview

The provided FDA 510(k) clearance letter and summary for the Respond OC Conserving Regulator (K250322) outlines the device, its intended use, and its substantial equivalence to a predicate device. However, this documentation does not contain the detailed information typically found in a clinical study report or a comprehensive test report regarding acceptance criteria and the study that proves the device meets them, especially in the context of AI/ML-based medical devices or diagnostic tools.

The device described (an oxygen conserving regulator) is a mechanical device, not an AI/ML-driven diagnostic or treatment device. Therefore, many of the typical requirements for AI/ML device studies (such as MRMC, expert consensus for ground truth, training set details, and specific performance metrics like sensitivity/specificity/AUC) are not applicable here.

The document primarily focuses on bench testing and biocompatibility to demonstrate substantial equivalence to a predicate mechanical device.

Here's an analysis based on the provided document, highlighting what is and is not present concerning "acceptance criteria" and "study proof":

Analysis of Acceptance Criteria and Study Proof for Respond OC Conserving Regulator (K250322)

Based on the provided FDA 510(k) Summary, the device is a mechanical oxygen conserving regulator. The "acceptance criteria" and "study proof" are framed in the context of demonstrating substantial equivalence to a predicate mechanical device through non-clinical (bench) testing and biocompatibility assessments, rather than clinical efficacy studies or AI/ML performance evaluations.

1. Table of Acceptance Criteria and Reported Device Performance

The document summarizes the types of tests conducted and states that the device "met its acceptance criteria" and "performs similarly to the predicate device." However, it does not explicitly list the specific quantitative acceptance criteria for each test (e.g., a specific tolerance for oxygen flow, a defined pass/fail for impact resistance) nor does it present the raw, quantitative reported performance results against these criteria. Instead, it provides qualitative statements of compliance.

Acceptance Criteria (Inferred from Test Types)	Reported Device Performance (as stated in document)
Biocompatibility:
ISO 18562-2 – Emissions of Particulate Matter	"met the applicable requirements for biocompatibility safety"
ISO 18562-3 – Emissions of VOCs with Toxicological Risk Assessment	"met the applicable requirements for biocompatibility safety"
Bench Testing:
Accelerated Aging performance	"demonstrated that the subject device met its acceptance criteria"
Flow Comparison with predicate	"performs similarly to the predicate device"
Flow Regulation Test performance	"demonstrated that the subject device met its acceptance criteria"
Conservation Testing savings ratio (e.g., 6:1)	"demonstrated that the subject device met its acceptance criteria" (specifically states 6:1 savings ratio achieved, similar to predicate)
Promoted Ignition Burst Pressure Test (ASTM G 175-24)	"Passed ASTM G 175-24" (similar to predicate's G 175-03)
Environmental Testing (e.g., temperature, humidity)	"demonstrated that the subject device met its acceptance criteria"
Altitude Test performance	"demonstrated that the subject device met its acceptance criteria"
Flow Response Test (e.g., bolus delivery, trigger)	"performs similarly to the predicate device"; "Conserve mode: Senses a breath and delivers in first 1/3 of breath cycle"
Impact Test performance	"demonstrated that the subject device met its acceptance criteria"
Functional Equivalence:
Selectable Outlet Flow (Continuous: 2, 3, 4 lpm); (Conserve: 1-5 lpm)	Match stated levels (Implicitly met for substantial equivalence claim)
Oxygen Bolus Size (ml) at 20 BPM (specific ml per lpm setting)	Conserve 1 lpm: 11 ml; 2 lpm: 24 ml; 3 lpm: 37 ml; 4 lpm: 46 ml; 5 lpm: 54 ml (Similar to predicate)
Regulator Outlet Pressure (22 PSI)	Match stated 22 PSI (Similar to predicate's 25 PSI)
Breaths Per Minute (bpm) support (Up to 35 bpm)	Met (Predicate: 14 to 40 bpm)

2. Sample Size for the Test Set and Data Provenance

Given this is a physical device, the "test set" refers to the manufactured units subjected to bench testing. The document does not specify the sample size (number of devices) used for each of the non-clinical tests (e.g., how many units were subjected to accelerated aging, or impact testing).

Data Provenance: The data provenance is from non-clinical bench testing conducted by the manufacturer, Responsive Respiratory, Inc. It's not clinical data or retrospective/prospective human data. The country of origin for the testing itself is not explicitly stated but would typically be where the manufacturer's testing facilities are located.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This question is not applicable as the device is a mechanical oxygen regulator, not an AI/ML-driven diagnostic or classification device requiring expert-established ground truth from medical images or patient data. Ground truth for its performance would be established through calibrated laboratory equipment measuring physical parameters (flow, pressure, timing, etc.) against engineering specifications.

4. Adjudication Method for the Test Set

This question is not applicable for a mechanical device undergoing bench testing. Adjudication typically refers to resolving discrepancies between human readers or between AI and human readings. Test results for mechanical parameters are either within specification or not, based on objective measurements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices (especially those using AI/ML) where human readers (e.g., radiologists) interpret cases, and the effectiveness of AI assistance on their performance is evaluated. The Respond OC Conserving Regulator is a therapeutic/delivery device, not a diagnostic one.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done

This question is not applicable in the typical sense for this device. There is no "algorithm" in the way an AI/ML device would have one. The device's "performance" is its mechanical function. The "bench testing" described in the summary is the standalone performance assessment of the device's mechanical and pneumatic operation (e.g., flow rates, bolus timing, pressure regulation) without human intervention beyond setting the controls for the test.

7. The Type of Ground Truth Used

For the bench tests, the "ground truth" would be physical measurements against engineering specifications and industry standards. For example:

Flow rates: Measured by calibrated flow meters against specified LPM settings.
Pressure: Measured by calibrated pressure gauges against specified PSI output.
Timing of bolus delivery: Measured by sensors and timers to confirm delivery within the specified inspiratory cycle.
Biocompatibility: Confirmed by laboratory analysis against ISO standards.
Ignition Sensitivity: Confirmed by testing against ASTM standards.

It is not expert consensus, pathology, or outcomes data, as these are related to clinical diagnosis or patient outcomes, not the performance of a mechanical oxygen delivery device.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" as this is not an AI/ML device that requires data for model training.

9. How the Ground Truth for the Training Set was Established

This question is not applicable for the same reason as point 8.

Summary

FDA 510(k) Clearance Letter - Respond OC Conserving Regulator

Page 1

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

Doc ID # 04017.08.00

July 24, 2025

Responsive Respiratory
℅ Paul Dryden
President
ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg, Florida 33704

Re: K250322
Trade/Device Name: Respond OC Conserving Regulator (130-0800)
Regulation Number: 21 CFR 868.5905
Regulation Name: Noncontinuous Ventilator (IPPB)
Regulatory Class: Class II
Product Code: NFB
Dated: June 22, 2025
Received: June 23, 2025

Dear Paul Dryden:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

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K250322 - Paul Dryden Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic.

Page 3

K250322 - Paul Dryden Page 3

See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Bradley Q. Quinn -S

Bradley Quinn
Assistant Director
DHT1C: Division of Anesthesia, Respiratory, and Sleep Devices
OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT, and Dental Devices
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

Page 4

FORM FDA 3881 (8/23) Page 1 of 1

DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

510(k) Number (if known): K250322

Device Name: Respond OC Conserving Regulator (130-0800)

Indications for Use (Describe):

Type of Use (Select one or both, as applicable):
☒ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

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Page 5

K250322 510(k) Summary

Page 1 of 6

Date Prepared: 22-Jul-25

Sponsor: Responsive Respiratory, Inc.
6244 Lemay Ferry Rd.
Saint Louis, MO 63129
Steve Bannon, President
(866) 333-4030

Submission Correspondent: Paul Dryden - ProMedic, LLC

Proprietary or Trade Name: Respond OC Conserving Regulator (130-0800)
Classification Name: Conserver, Oxygen
Product Code: NFB
CFR: 21 CFR 868.5905

Proprietary or Trade Name: Chad Therapeutics Bonsai Model 800 – K070740
Classification Name: Conserver, Oxygen
Product Code: NFB
CFR: 21 CFR 868.5905

Device Description

Principle of Operation

The Respond OC Conserving Regulator (130-0800) is a dual mode device allowing for both continuous and conserve flows. Oxygen flow rates are adjusted by setting an external flow control knob to the prescribed rate. In continuous mode, the Respond OC functions as a standard continuous flow regular, similar to traditional click-style regulators. In conserve mode, the unit acts as a conserving device, which increases the ambulatory time over that of continuous flow systems. The flow of oxygen is controlled by the patient's inhalation, which triggers a sensing diaphragm within the control module to release a bolus of oxygen directly into the lungs at the beginning of the inhalation cycle.

Indications for Use:

Patient Population:

Patients that require supplemental oxygen in their home and for ambulatory use.

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K250322 510(k) Summary

Page 2 of 6

Environments of use:

Home and ambulatory use.

Substantial Equivalence Discussion

Indications for Use –

The indications for use for the subject and predicate devices are similar. We have updated the Indications for Use language to mirror more recent submissions.

Discussion – The indications for use between the subject and predicate device are similar.

Technology and construction –

The Respond OC Conserving Regulator (130-0800) is a combination high pressure oxygen regulator and conserving device. The unit operates similarly to other oxygen conservers currently on the market today wherein the device contains a traditional oxygen regulator coupled with a conserver. It is constructed with a CGA 870 yoke for use with high pressure oxygen cylinders and utilizes an aluminum unibody design with brass componentry in the high pressure areas. The device requires no electrical power source. Operating pressure range is 300 – 3000 psig with a nominal outlet pressure of 22 psi.

The device uses a single lumen cannula attached to a single outlet port that delivers oxygen to the patient. In regulator (steady flow) mode, the device features selectable flows of 1-5 LPM equivalence in 1 LPM increments. Flow rates are adjustable by a click-style flow control knob that allows adjustment between both steady flow or conserve flows without having to turn the device or flow of oxygen off. In the conserve mode, the flow of oxygen is triggered and controlled by the patient respiratory cycle. Upon inhalation, the sensing diaphragm within the control module is triggered to release a bolus of oxygen to the patient. No oxygen is delivered during exhalation.

The technology utilized within the device is substantially equivalent to the predicate device – Chad Therapeutics Bonsai. Both units are pneumatic devices designed for use with CGA 870 connections on high pressure oxygen cylinders and are combination devices offering conserve and continuous flow modes of oxygen delivery to the patient. Each device utilizes a click-style knob to select delivery modes and oxygen flow settings. In conserve mode, both devices utilize a sensing diaphragm to sense the inhalation/exhalation cycle and deliver a bolus of oxygen to the patient. Further, both units include similar materials of construction, input operating pressures, outlet pressures, inlet configuration, outlet connection, gauges, inhalation trigger points, oxygen conservation percentages and weight.

The functional differences between the units include body styles and the length of oxygen bolus delivery during inhalation. Since pulse is a fixed time and the breath rate is variable, the percent of the breath that the pulse uses is a function of the breath rate.

At 15 BPM, the total breath is 4 seconds. With an assumed 1:1 I:E ratio, the inhale time is 2 seconds
At 20 BPM, the total breath is 3 seconds. With an assumed 1:1 I:E ratio, the inhale time is 1.5 seconds
At 30 BPM, the total breath is 2 seconds and the same assumed 1:1 I:E ratio, the inhale time decreases to 1 second.
Using the above examples, the differential between the delivery and length of the bolus fluctuates between .4 second difference at 15 BPM, to less than .2 seconds at 30 BPM.

Discussion – The differences do not raise different questions of safety and effectiveness.

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K250322 510(k) Summary

Page 3 of 6

Environment of Use –

The environment of use is identical.

Discussion – The environments of use are similar to the predicate – Chad Therapeutics Bonsai Model 800 – K070740.

Patient Population –

The patient population of the subject device and predicate is identical.

Discussion – The patient population is equivalent to the predicate device – Chad Therapeutics Bonsai Model 800 – K070740.

Non-Clinical Testing Summary –

Performance testing demonstrated that the subject device met its acceptance criteria. Testing included:

Biocompatibility

ISO 18562-2 – Emissions of Particulate Matter
ISO 18562-3 – Emissions of VOCs with Toxicological Risk Assessment

Bench testing

Accelerated Aging
Flow Comparison
Flow Regulation Test
Conservation Testing
Promoted Ignition Burst Pressure Test
Environmental Testing
Altitude Test
Flow Response Test
Impact Test

Bench testing –
Performance testing demonstrated that the subject device performs similarly to the predicate device.

Discussion – The test results are similar to the predicate and within pre-defined acceptance criteria.

Biocompatibility –
Discussion – The subject device was found to meet the applicable requirements for biocompatibility safety for the intended population.

Discussion of Differences

The subject device indications for use are similar to the predicate. We have removed the "modified" and "unmodified" language from the predicate device Indications for Use. Also, we have reorganized the language to detail that the device also delivers a constant flow of oxygen, which is the same as the predicate but was not specified in its indications for use statement. We have also removed "i.e., for prescription use only."

At 15 BPM, the total breath is 4 seconds. With an assumed 1:1 I:E ratio, the inhale time is 2 seconds
At 20 BPM, the total breath is 3 seconds. With an assumed 1:1 I:E ratio, the inhale time is 1.5 seconds

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K250322 510(k) Summary

Page 4 of 6

At 30 BPM, the total breath is 2 seconds and the same assumed 1:1 I:E ratio, the inhale time decreases to 1 second.
Using the above examples, the differential between the delivery and length of the bolus fluctuates between .4 second difference at 15 BPM, to less than .2 seconds at 30 BPM.

Discussion – The differences do not raise different questions of safety and effectiveness.

Substantial Equivalence Conclusion

Through testing, the subject device has demonstrated it is substantially equivalent to the predicate device – Chad Therapeutics Bonsai Model 800 – K070740.

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K250322 510(k) Summary

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Comparative Characteristics	Subject Device Respond OC	Predicate Device Bonsai Model 800 K070740	Similarities / Differences
Manufacturer	Responsive Respiratory, Inc.	Chad Therapeutics
Prescription Device	Yes	Yes	Similar
Device classification and Product Code	NFB 868.5905	NFB 868.5905	Similar
Indications for Use	The Respond OC Conserving Regulator is intended for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use. It may also be used to deliver a constant flow of oxygen to the patient.	The Chad Therapeutics Bonsai (modified Chad Therapeutics OXYPNEUMATIC CYPRESS Model 511) is intended for use in the same manner as the unmodified device, i.e., for prescription use only, to be used as part of a portable oxygen delivery system for patients that require supplemental oxygen in their home and for ambulatory use.	Similar. The subject device indications for use are similar to the predicate. We have removed the "modified" and "unmodified" language from the predicate device Indications for Use. Also, we have reorganized the language to detail that the device also delivers a constant flow of oxygen, which is the same as the predicate but was not specified in its indications for use statement. We have also removed "i.e., for prescription use only."
Contraindications	None	None	Similar
Patient Population	Patients that require supplemental oxygen in their home and for ambulatory use	Patients that require supplemental oxygen in their home and for ambulatory use	Similar
Environment of Use	Home and ambulatory use	Home and ambulatory use	Similar
Oxygen Supply	Compressed oxygen cylinder 300 to 3,000 psig	Compressed oxygen cylinder 500 to 3,000 psig	Similar
Cylinder Configuration	CGA 870 Valve	CGA 870 Valve	Similar
Technology	Delivers a pulsed dose of oxygen to patient by sensing inhalation utilizing a standard nasal cannula of 7ft or less in length.	Delivers a pulsed dose of oxygen to patient by sensing inhalation utilizing a standard nasal cannula of 7ft or less in length.	Similar
Pneumatic Design – Non Electric	Yes	Yes	Similar
Features
Cannula Length	Uses standard single lumen cannula up to 7ft in length	Uses standard single lumen cannula up to 7ft in length	Similar Note: nasal cannula is user supplied

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K250322 510(k) Summary

Page 6 of 6

Comparative Characteristics	Subject Device Respond OC	Predicate Device Bonsai Model 800 K070740	Similarities / Differences
Design	2-in-1 design allows patients to switch from conservation mode to standard continuous regulator mode.	Delivers a uniform oxygen pulse at increments. Can be switched to continuous mode.	Similar
Trigger Method	Inspiratory Effort, Negative Pressure	Inspiratory Effort, Negative Pressure	Similar
Conserve Mode	Senses a breath and delivers in first 1/3 of breath cycle	Senses a breath/delivers oxygen in the first half of the inspiratory cycle	Similar. Both devices deliver oxygen within a similar time period in the early stages of the inhalation cycle
Selectable Outlet Flow	Continuous – 2, 3, 4 lpm	Continuous – 2 and 4 lpm	Similar
	Conserve – 1-5 lpm	Conserve – 1-6 lpm	Similar
Oxygen Bolus Size (ml) At 20 BPM	Conserve 1 lpm: 11 mlConserve 2 lpm: 24 mlConserve 3 lpm: 37 mlConserve 4 lpm: 46 mlConserve 5 lpm: 54 ml	Conserve 1 lpm: 11 mlConserve 2 lpm: 29 mlConserve 3 lpm: 41 mlConserve 4 lpm: 50 mlConserve 5 lpm: 56 mlConserve 6 lpm: 58 ML	Similar
Outlet Configuration	Cannula Hose Barb	Cannula Hose Barb	Similar
Regulator Outlet Pressure	22 PSI	25 PSI	Similar
Breaths Per Minute (bpm)	Up to 35	14 to 40	Similar
Savings Ration	6:1	6:1	Similar
Ignition Sensitivity and Fault Tolerance	Passed ASTM G 175-24	Passed ASTM G 175-03	Similar

Regulation Number and Section

§ 868.5905 Noncontinuous ventilator (IPPB).

(a)
Identification. A noncontinuous ventilator (intermittent positive pressure breathing-IPPB) is a device intended to deliver intermittently an aerosol to a patient's lungs or to assist a patient's breathing.(b)
Classification. Class II (performance standards).