The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.

The sizes versions also include indications for the patient population:

Adult: The Adult model is intended for patients over 20 kg (44 lbs).
Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs).
Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs).

The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.

The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.

Device Description

The BAG is a non-sterile self-inflating manual resuscitator. It is indicated for patients requiring ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG manual resuscitator is intended for short-term use (< 24 hours per patient) and may be used multiple times on a single patient when kept free from contamination. It is available in three sizes: adult (for patients > 20 kg (44 lbs.)), pediatric (for patients 2.5-20 kg (5.5-44 lbs.)), and newborn (for patients 2.5-5 kg (5.5-11 lbs.)).

AI/ML Overview

N/A

Summary

FDA 510(k) Clearance Letter - The BAG Manual Resuscitator and Accessories

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

Doc ID # 04017.08.02

November 24, 2025

Laerdal Medical AS
℅ Daniel Dillon
Senior Regulatory Scientist
MED Institute
1330 Win Hentschel Boulevard
Suite 100
West Lafayette, Indiana 47906

Re: K251631
Trade/Device Name: The BAG manual resuscitator and accessories
Regulation Number: 21 CFR 868.5915
Regulation Name: Manual Emergency Ventilator
Regulatory Class: Class II
Product Code: BTM, BYE, CAP
Dated: May 27, 2025
Received: May 28, 2025

Dear Daniel Dillon:

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.

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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" (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. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-

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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,

John S. Bender -S

for Ethan Nyberg, Ph.D.
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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration

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

Indications for Use

Submission Number (if known): K251631

Device Name: The BAG manual resuscitator and accessories

Indications for Use (Describe)

The sizes versions also include indications for the patient population:

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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"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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510(k) Summary

The BAG manual resuscitator

21 CFR 868.5915

Date Prepared: November 20, 2025

Submitted By
Claudia Pajares Ibanez, Manager, Regulatory Affairs
Laerdal Medical AS
Tanke Svilandsgate 30
P.O. Box 377
4002 Stavanger
Norway
T: (011) 47-51-51-1892
Claudia.Pajares.Ibanez@laerdal.com

Device Information

The BAG manual resuscitator and accessories have the following names and classifications:

Trade Name	Common Name	Classification Name	Regulation Class	Product Code
The BAG	manual resuscitator	Manual emergency ventilator	868.5915	II
The BAG	PEEP valve	Positive end expiratory pressure breathing attachment	868.5965	II
The BAG	Manometer	Airway pressure monitor	868.2600	II

Indications for Use

The sizes versions also include indications for the patient population:

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Substantial Equivalence

The BAG manual resuscitator is substantially equivalent to the Flexicare Single Use Resuscitator Bag (510(k) No. K181583, cleared December 7, 2018).

The BAG PEEP Valve is substantially equivalent to the PEEP valve described in the 510(k) for the Hsiner Resuscitator and PEEP Valve (510(k) No. K053466, cleared March 22, 2006).

The BAG Manometer is substantially equivalent to the Intersurgical 7160030 Manometer (510(k) No. K122077, cleared January 10, 2013).

Device Description

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Predicate Devices

The three tables below present the similarities and differences between the subject and predicate devices and the predicate devices for substantial equivalence purposes. The differences between the subject and predicate devices do not raise new questions of safety or effectiveness and support substantial equivalence.

Performance

Performance data are available to support substantial equivalence and were developed using acceptable scientific methods for evaluation.

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Table 1 Comparison of The BAG manual resuscitator to the Flexicare Single Use Resuscitator Bag (K181583)

Intended use	The BAG manual resuscitator Subject of this submission	Flexicare Single Use Resuscitator Bag (K181583)	Comparison
	Provides emergency respiratory support by delivering positive pressure to a patient's airway. The subject device is intended for use in both pre-hospital and healthcare facility environments.	Provides emergency respiratory support by delivering positive pressure to a patient's airway. The subject device is intended for use in both pre-hospital and healthcare facility environments.	Equivalent. Indications for use are very similar. Indications for use are the same way, yet substantial equivalence is supported because the two devices have the same intended use.
Indications for use	The BAG is indicated for patients requiring total or intermittent ventilatory support. Ventilation is possible with or without supplemental oxygen. The BAG is intended to be used in both pre-hospital and healthcare facility environments.	The Flexicare Single Use Resuscitator Bag is indicated for manual pulmonary resuscitation for emergency resuscitation and temporary ventilatory support of patients in respiratory distress or failure.	Equivalent. Indications for use are the same way, yet substantial equivalence is supported because the two devices have the same intended use.
	The sizes versions also include indications for the patient population: Adult: The Adult model is intended for patients over 20 kg (44 lbs). Pediatric: The Pediatric model is intended for patients 2.5 - 20 kg (5.5 - 44 lbs). Newborn: The Newborn model is intended for patients 2.5 - 5 kg (5.5 -11 lbs).		Same. The predicate device includes the same components as the BAG. The predicate device is available in the same patient population sizes within the range of The BAG manual resuscitator's patient population is within the range of the predicate's patient population.

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	Prescription status	Prescription use only	Prescription use only	Same
	Environment of use	Healthcare facilities, pre-hospital	Healthcare facilities, pre-hospital	Same
	Intended users	Healthcare professionals trained in resuscitation techniques and the use of manual resuscitators	Healthcare professionals trained in resuscitation techniques and the use of manual resuscitators	Same
Design	Principle of operation	Manual inflation of bags via bag with stores air/oxygen mixture and delivers it to the patient via attachment to breathing circuit and/or patient's breathing circuit	Manual inflation of bags via bag with stores air/oxygen mixture and delivers it to the patient via attachment to breathing circuit and/or patient's breathing circuit	Same
	Key materials	Silicone	Silicone	Same
	Reuse status	Single patient use - 24 hours	Single patient use - 24 hours	Same
	Sterilization	Not sterilized	Not sterilized	Same

Performance

| | Tidal volume | Adult: 1.2 cmH₂O @ 50 L/min Pediatric: 4.0 cmH₂O @ 15 L/min Newborn: 0.5 cmH₂O @ 5 L/min | Adult: 1.5 cmH₂O @ 50 L/min Pediatric: 1.7 cmH₂O @ 15 L/min Newborn: 0.9 cmH₂O @ 5 L/min | Equivalent. The predicate device includes the same components as the BAG. The predicate device is available in the same patient population sizes within the range of The BAG manual resuscitator's patient population is within the range of the predicate's patient population. |
| | Expiratory resistance | Adult: ≤ 5 cmH₂O @ 50 L/min Pediatric: ≤ 5 cmH₂O @ 15 L/min Newborn: ≤ 5 cmH₂O @ 5 L/min | Adult: ≤ 5 cmH₂O @ 50 L/min Pediatric: ≤ 5 cmH₂O @ 15 L/min Newborn: ≤ 5 cmH₂O @ 5 L/min | Same |
| | Packaging volume | Adult: 690 ml Pediatric: 450 ml | Adult: 42 ml Pediatric: 50 ml | Equivalent. Although the predicate device uses different wording to describe the intended uses, the intended uses are substantially the same. |

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Maximum pressure relief	Adult: 60 ± 5 cmH₂O @ 60 L/min Pediatric: 40 ± 4 cmH₂O @ 30 L/min Newborn: 40 ± 4 cmH₂O @ 15 L/min	Adult: Three versions (1) 60 cmH₂O (2) 40 cmH₂O over 40 cmH₂O Pediatric: 40 cmH₂O Newborn: 40 cmH₂O	Equivalent. The BAG Manometer is more accurate than the predicate device. The BAG Manometer can be performed with a practically performed and the BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.

Inspiratory resistance	Adult: ≤ 5 cmH₂O @ 50 L/min Pediatric: ≤ 5 cmH₂O @ 15 L/min Newborn: ≤ 5 cmH₂O @ 5 L/min	Adult: ≤ 5 cmH₂O @ 50 L/min Pediatric: ≤ 5 cmH₂O @ 15 L/min Newborn: ≤ 5 cmH₂O @ 5 L/min	Same

Oxygen concentration	Adult: ≥ 85% O₂ @ 15 L/min O₂ flow with reservoir Pediatric: ≥ 85% O₂ @ 10 L/min O₂ flow with reservoir Newborn: ≥ 85% O₂ @ 5 L/min O₂ flow with reservoir	Adult: ≥ 85% O₂ @ 15 L/min O₂ flow with reservoir Pediatric: ≥ 85% O₂ @ 10 L/min O₂ flow with reservoir Newborn: ≥ 85% O₂ @ 5 L/min O₂ flow with reservoir	Same

Oxygen concentration without reservoir	Adult: 21% O₂ Pediatric: 21% O₂ Newborn: 21% O₂	Adult: 21% O₂ Pediatric: 21% O₂ Newborn: 21% O₂	Same

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Table 2 Comparison of The BAG PEEP Valve to the Hsiner PEEP Valve (K053466)

Intended use	The BAG PEEP Valve Subject of this submission	Hsiner PEEP Valve (K053466)	Comparison
	Excess pressure in a patient's lungs above atmospheric pressure at the end of each breath.	Excess pressure in a patient's lungs above atmospheric pressure at the end of each breath.	Equivalent. The substantial equivalence of the device with respect to materials, design, and biocompatibility evaluation using FDA-recognized consensus standards.
Indications for use	The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.	The BAG PEEP Valve is indicated for patients in need of ventilatory support with positive end-expiratory pressure (PEEP). The BAG PEEP valves can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG PEEP valve is intended to be used in both pre-hospital and healthcare facility environments.	Same. The substantial equivalence of the device with respect to materials, design, and biocompatibility evaluation using FDA-recognized consensus standards.
Prescription status	Prescription use only	Not stated	Equivalent. The predicate device includes the same components as the BAG. The predicate device is available in the same patient population sizes within the range of The BAG manual resuscitator's patient population is within the range of the predicate's patient population.
Environment of use	Healthcare facilities, pre-hospital	Not stated	Same
Intended users	Healthcare professionals trained in resuscitation, delivering ventilatory support with PEEP and in the use of manual resuscitators.	Healthcare professionals trained in resuscitation, delivering ventilatory support with PEEP and in the use of manual resuscitators.	Same

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Principle of operation	Adjustable spring-actuated valve	Adjustable spring-actuated valve	Same
Key components	• Valve • Spring • Housing • Inlet • Spring • Housing	• Valve • Spring • Housing • Inlet • Spring • Housing	Same
Key materials	Silicone	Not stated	Equivalent. Although the predicate device uses different wording to describe the intended uses, the intended uses are substantially the same.
Reuse status	Single patient use only	Single patient use only	Same

Performance

	Pressure range	0-60 cmH₂O in 10 cmH₂O increments	5-20 cmH₂O 2.5 cmH₂O increments	Equivalent. The BAG Manometer is more accurate than the predicate device. The BAG Manometer can be performed with a practically performed and the BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.
	Accuracy	± 2 cmH₂O	Not stated	Same with clarification of length of use, which does not affect substantial equivalence.

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Table 3 Comparison of The BAG Manometer to the Intersurgical 7160030 Manometer (K122077)

Intended use	The BAG Manometer Subject of this submission	Intersurgical 7160030 Manometer (K122077)	Comparison
	Measures the pressure in a patient's upper airway.	Measures the pressure in a patient's upper airway.	Same
Indications for use	The BAG Manometer is indicated for measuring the gas pressure provided to a patient requiring total or intermittent ventilatory support. The BAG Manometer can be used for all patient sizes indicated for The BAG manual resuscitator. The BAG Manometer is intended to be used in both pre-hospital and healthcare facility environments.	The Intersurgical 7160030 Manometer is indicated for manual pulmonary resuscitation for emergency resuscitation and temporary ventilatory support of patients in respiratory distress or failure.	Equivalent. Indications for use are the same way, yet substantial equivalence is supported because the two devices have the same intended use.
Prescription status	Prescription use only	Prescription use only	Same
Environment of use	Healthcare facilities, pre-hospital	Hospital, ambulance and all other environments	Equivalent. The predicate device includes the same components as the BAG. The predicate device is available in the same patient population sizes within the range of The BAG manual resuscitator's patient population is within the range of the predicate's patient population.
Intended users	Healthcare professionals trained in resuscitation, delivering ventilatory support and/or airway resuscitation.	Healthcare professionals trained in resuscitation, delivering ventilatory support and/or airway resuscitation.	Same

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Principle of operation	A balance of the force exerted by the air in the system and the force exerted by a calibrated spring. The manometer is a simple for use and does not require a manometer is a simple for use and does not require a specific level of the airway pressure cylinder manometer is intended to be used in both pre-hospital and healthcare facility environments.	A balance of the force exerted by the air in the system and the force exerted by a calibrated spring. The manometer is a simple for use and does not require a manometer is a simple for use and does not require a specific level of the airway pressure cylinder manometer is intended to be used in both pre-hospital and healthcare facility environments.	Same
Key components	• Ventilation bag • Patient valve and pressure relief valve • Oxygen reservoir • Manometer option • CO₂ monitoring port • Face mask	• Ventilation bag • Patient valve and pressure relief valve • Oxygen reservoir • Manometer option • CO₂ monitoring port • Face mask	Same
Key materials	Nonsterile	Nonsterile	Same
Reuse status	Single use	Single use	Same

Performance

	Pressure range	0-60 cmH₂O in 10 cmH₂O increments	±2 mbar (2 cmH₂O @ 30 L/min ±5 mbar (5 cmH₂O @ 30 L/min ±4 mbar (4 cmH₂O @ 15 L/min ±7 mbar (7 cmH₂O @ 60 L/min	Equivalent. The predicate device includes the same components as the BAG. The predicate device is available in the same patient population sizes within the range of The BAG manual resuscitator's patient population is within the range of the predicate's patient population.
	Accuracy	±2 cmH₂O	Unknown	Same

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Discussion of Tests and Test Results

Design verification and design validation testing demonstrates that The BAG manual resuscitator and accessories meet their functional requirements and performance specifications. In particular, testing was conducted on:

• The BAG manual resuscitator, in accordance with:

○ ISO 10651-4:2002, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators, using the resuscitator alone and with all accessories,

○ ISO 5356-1:2015, Anaesthetic and respiratory equipment – Conical connectors – Part 1: Cones and sockets.

• The BAG manual resuscitator, for maximum deliverable tidal volume, dead space, and operation for 24 hours, in accordance with ISO 10651-4:2023, Lung ventilators – Part 4: Particular requirements for operator-powered resuscitators.

• The BAG PEEP Valve, for accuracy, using the operation and storage conditions and simulated ventilations from ISO 10651-4:2002.

• The BAG Manometer, for accuracy, using the operation and storage conditions from ISO 10651-4:2002.

• All accessories, for label durability and ability to withstand drops.

• All devices (separate and combined), for magnetic resonance compatibility in accordance with:

○ ASTM F2052-21, Standard Test Method for Measurement of Magnetically Induced Displacement Force on Medical Devices in the Magnetic Resonance Environment, and

○ ASTM F2213-17, Standard Test Method for Measurement of Magnetically Induced Torque on Medical Devices in the Magnetic Resonance Environment.

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Predicate Devices

The three tables below present the similarities and differences between the subject and predicate devices for substantial equivalence purposes. The differences between the subject and predicate devices do not raise new questions of safety or effectiveness and support substantial equivalence.

Performance

Performance data are available to support substantial equivalence and were developed using acceptable scientific methods for evaluation.

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Discussion of Tests and Test Results

The BAG manual resuscitator, in accordance with:
- ISO 10993-1:2018, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process,
- ISO 18562-1:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 1: Evaluation and testing within a risk management process,
- ISO 18562-2:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 2: Tests for emissions of particulate matter,
- ISO 18562-3:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 3: Tests for emissions of volatile organic compounds, and
- ISO 18562-4:2017, Biocompatibility evaluation of breathing gas pathways in healthcare applications - Part 4: Tests for leachables in condensate.
All devices combined, for human factors in accordance with:
- FDA's guidance, Applying Human Factors and Usability Engineering to Medical Devices (2016)
- FDA's guidance, Content of Human Factors Information in Medical Device Marketing Submissions (2022)
- IEC 62366-1, Edition 1.1 2020-06 Consolidated Version, Medical devices - Part 1: Application of usability engineering to medical device
The packaging of all devices, for ability to withstand expected shipping conditions, in accordance with ISTA 3A:2008, Packaged-products for parcel delivery system shipment 70 kg (150 lb) or less.

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All devices, at the end of their shelf life, for continued compliance with performance requirements.

Conclusion

The results of these tests support the conclusion that The BAG manual resuscitator and accessories perform acceptably and do not raise any different questions regarding safety or effectiveness compared to the predicate devices, thus supporting a determination of substantial equivalence.

Regulation Number and Section

§ 868.5915 Manual emergency ventilator.

(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).