(264 days)
Not Found
No.
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and describes a breath-actuated nebulizer that operates based on the patient's inspiratory cycle, which is a mechanical or sensor-based function, not indicative of an AI model.
Yes
This device is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional, which makes it a therapeutic device used in the treatment of patients.
No
The device is described as a nebulizer intended for the administration of aerosolized medication, not for diagnosing conditions.
No
The device is a hardware-based nebulizer that administers aerosolized medication and operates with a compressed air source. It is not described as residing on a computing platform with software as its primary mechanism of action. The performance studies focus on physical characteristics of the aerosol, not software-driven metrics.
No.
The device is a nebulizer for administering aerosolized medication, not for performing in vitro diagnostic examinations of specimens derived from the human body.
N/A
Intended Use / Indications for Use
AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.
Product codes (comma separated list FDA assigned to the subject device)
CAF
Device Description
AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adults and pediatric patients over 5 years old
Intended User / Care Setting
licensed healthcare provider or physician; home or in hospitals and clinics.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Comparative Performance studies were conducted for the subject device (AllNEB - K242354) and the predicate device (AeroEclipse II Breath Actuated Nebulizer - K053605) for various medications (Albuterol Sulfate, Ipratropium Bromide, Cromolyn Sodium) at different flow rates (5 lpm, 8 lpm) in both Breath Actuated Mode and Constant-Output Mode, for adult and pediatric settings.
Key results generally show similar performance between the subject device and the predicate across metrics such as:
- MMAD (Mass Median Aerodynamic Diameter)
- GSD (Geometric Standard Deviation)
- Total Dose Delivered
- Total Respirable Dose (0.5-5 um)
- Coarse Particle Dose (>4.7 um)
- Fine Particle Dose (4.7 um), Fine Particle Dose (
§ 868.5630 Nebulizer.
(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).
FDA 510(k) Clearance Letter - AllNEB Breath Actuated Nebulizer
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov
Doc ID # 04017.07.05
April 29, 2025
Enchant Tek Co. Ltd.
℅ Paul Dryden
President
ProMedic, LLC
131 Bay Point Dr. NE
St. Petersburg, Florida 33704
Re: K242354
Trade/Device Name: AllNEB
Regulation Number: 21 CFR 868.5630
Regulation Name: Nebulizer
Regulatory Class: Class II
Product Code: CAF
Dated: April 1, 2025
Received: April 1, 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"
Page 2
K242354 - 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. 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).
Page 3
K242354 - Paul Dryden Page 3
Sincerely,
Ethan L. Nyberg -S
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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
Indications for Use
See PRA Statement below.
510(k) Number (if known)
K242354
Device Name
AllNEB Breath Actuated Nebulizer
Indications for Use (Describe)
AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.
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.
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DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
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FORM FDA 3881 (8/23) Page 1 of 1
Page 5
K242354 510(k) Summary
Page 1 of 12
Date Prepared: 29-Apr-25
Sponsor: Enchant Tek Co. Ltd.
No. 210 Xiangzhong Rd.
Dongshan Township, Yilan County
Taipei, TW 26950
Tel +886- 03-959-3500
Sponsor Contact: Ling Leonard – QA/RA Supervisor
Submission Correspondent: Paul Dryden
ProMedic, LLC
Proprietary or Trade Name: AllNEB
Common/Usual Name: Nebulizer
Classification Name: Nebulizer (direct patient interface) 21CFR 868.5630
Product Code: CAF
Predicate Device: AeroEclipse II Breath Actuated Nebulizer – K053605
Common/Usual Name: Nebulizer
Classification Name: Nebulizer (direct patient interface) 21CFR 868.5630
Product Code: CAF
Device Description: AllNEB is a jet nebulizer intended to administer medication (prescribed by a physician or health care provider) in the form of an aerosol for patient inhalation. It operates in conjunction with a compressed air source and a liquid medication. The subject device is designed to produce and deliver aerosolized medication only during the patient inspiratory cycle, reducing fugitive emissions to the environment. It can be used in hospitals, clinics and in the home.
Principle of Operation: The gas orifice is located in the center of the nebulizer. The driving gas (air or oxygen) passes through the small orifice and is deflected by a baffle on the actuator. The high velocity jet of gas produces a negative pressure behind it, which draws liquid up to the nozzle area. The deflected gas flow shears off the liquid being drawn up which generates the aerosol.
Indications for Use:
AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics.
Patient Population:
Pediatrics (5 years and older) to Adults.
Page 6
K242354 510(k) Summary
Page 2 of 12
Environments of use:
Home, hospitals, and clinics.
| Subject Device AllNEB – K242354 | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | Comment | |
|---|---|---|---|
| Manufacturer | Enchant | Trudell Medical International | |
| Prescriptive | Rx | Rx | Similar |
| Classification | 21 CFR 868.5630 - CAF Nebulizer - Direct patient interface | 21 CFR 868.5630 - CAF Nebulizer - Direct patient interface | Similar |
| Indications for use | AllNEB Breath Actuated Nebulizer is intended for adults and pediatric patients over 5 years old, who are under the care or treatment of a licensed healthcare provider or physician. AllNEB is intended for the administration of aerosolized medication prescribed by a physician or healthcare professional. AllNEB is to be used at home or in hospitals and clinics. | The AeroEclipse* II Breath Actuated Nebulizer is intended to be used by patients who are under the care or treatment of a licensed healthcare provider or physician. The device is intended to be used by these patients to administer aerosolized medication prescribed by a physician or health care professional. The intended environments for use include the home, hospitals and clinics. | The predicate device does not disclose the patient age range. |
| Intended Use Environment | Home or in hospitals and clinics | Home or in hospitals and clinics | Similar |
| Principle of Operation | Pneumatic Jet Nebulizer | Pneumatic Jet Nebulizer | Similar |
| Aerosolization Mode | Built-in mode selector for breath actuated or continuous mode | Built-in mode selector for breath actuated or continuous mode | Similar |
| Single Patient Use | Yes | Yes | Similar |
| Type of Device | Single patient use, multiple use, prescription only, non-sterile | Single patient use, multiple use, prescription only, non-sterile | Similar |
| Type of gas source | Compressed air or oxygen | Compressed air or oxygen | Similar |
| Flow Rate | 5 – 8 lpm (liters per minute) | 2.75 – 8 lpm (liters per minute) | Similar |
| Maximum Fill Volume | 6ml | 6ml | Similar |
| Basic Components | BAN with Mouthpiece, Oxygen Tubing | BAN with Mouthpiece, Oxygen Tubing | Similar Oxygen tubing is user supplied |
Page 7
K242354 510(k) Summary
Page 3 of 12
| Subject Device AllNEB – K242354 | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | Comment | |
|---|---|---|---|
| Biocompatibility | Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration ISO 10993-1 and ISO 18562-1 | Surface Contact, mucosal and Externally Communicating, Tissue contact, Permanent Duration | Similar |
| Subject Device AllNEB - 242354 | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | Comment |
|---|
Comparative Performance
Breath Actuated Mode – Adult settings
| MMAD | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 1.51 | 8 lpm: 2.03 | Albuterol Sulfate | 5 lpm: 2.03 | 8 lpm: 2.23 |
| Ipratropium Bromide | 1.47 | 1.90 | Ipratropium Bromide | 1.93 | 2.23 |
| Cromolyn Sodium | 1.50 | 1.87 | Cromolyn Sodium | 2.00 | 2.07 |
| GSD | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 2.43 | 8 lpm: 1.67 | Albuterol Sulfate | 5 lpm: 1.70 | 8 lpm: 1.63 |
| Ipratropium Bromide | 2.13 | 1.67 | Ipratropium Bromide | 1.67 | 1.70 |
| Cromolyn Sodium | 2.29 | 1.70 | Cromolyn Sodium | 1.70 | 1.73 |
| Total Dose Delivered | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 1,228 | 8 lpm: 1,293 | Albuterol Sulfate | 5 lpm: 1,367 | 8 lpm: 1,474 |
| Ipratropium Bromide | 188 | 208 | Ipratropium Bromide | 203 | 242 |
| Cromolyn Sodium | 5,255 | 5,781 | Cromolyn Sodium | 5,868 | 6,505 |
Page 8
K242354 510(k) Summary
Page 4 of 12
| Subject Device AllNEB - K242354 | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | Comment |
|---|
| Total Respirable Dose (0.5-5 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 834 | 8 lpm: 862 | Albuterol Sulfate | 5 lpm: 847 | 8 lpm: 899 |
| Ipratropium Bromide | 129 | 136 | Ipratropium Bromide | 132 | 138 |
| Cromolyn Sodium | 3,635 | 4,070 | Cromolyn Sodium | 3,681 | 4,030 |
| Coarse Particle Dose (>4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 218 | 8 lpm: 258 | Albuterol Sulfate | 5 lpm: 350 | 8 lpm: 426 |
| Ipratropium Bromide | 30 | 43 | Ipratropium Bromide | 48 | 76 |
| Cromolyn Sodium | 868 | 904 | Cromolyn Sodium | 1,411 | 1,549 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 208 | 8 lpm: 256 | Albuterol Sulfate | 5 lpm: 341 | 8 lpm: 446 |
| Ipratropium Bromide | 35 | 41 | Ipratropium Bromide | 48 | 68 |
| Cromolyn Sodium | 832 | 1,127 | Cromolyn Sodium | 1,450 | 1,831 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Ipratropium Bromide | 35 | 41 | Ipratropium Bromide | 48 | 68 |
| Cromolyn Sodium | 832 | 1,127 | Cromolyn Sodium | 1,450 | 1,831 |
| Albuterol Sulfate | 5 lpm: 1,025 | 8 lpm: 1,111 | Albuterol Sulfate | 5 lpm: 1,036 | 8 lpm: 1,017 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 266.1 | 8 lpm: 234 | Albuterol Sulfate | 5 lpm: 595.5 | 8 lpm: 570 |
| Ipratropium Bromide | 41.6 | 38 | Ipratropium Bromide | 84.2 | 95 |
| Cromolyn Sodium | 916.3 | 833 | Cromolyn Sodium | 1907.3 | 2326 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 266.1 | 8 lpm: 234 | Albuterol Sulfate | 5 lpm: 595.5 | 8 lpm: 570 |
| Ipratropium Bromide | 41.6 | 38 | Ipratropium Bromide | 84.2 | 95 |
| Cromolyn Sodium | 916.3 | 833 | Cromolyn Sodium | 1907.3 | 2326 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 250 | 8 lpm: 220 | Albuterol Sulfate | 5 lpm: 577 | 8 lpm: 556 |
| Ipratropium Bromide | 36 | 36 | Ipratropium Bromide | 94 | 81 |
| Cromolyn Sodium | 1021 | 921 | Cromolyn Sodium | 2180 | 2450 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 173 | 8 lpm: 189 | Albuterol Sulfate | 5 lpm: 275 | 8 lpm: 315 |
| Ipratropium Bromide | 24 | 33 | Ipratropium Bromide | 36 | 56 |
| Cromolyn Sodium | 678 | 701 | Cromolyn Sodium | 1,130 | 1,179 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 87 | 8 lpm: 106 | Albuterol Sulfate | 5 lpm: 139 | 8 lpm: 184 |
| Ipratropium Bromide | 15 | 17 | Ipratropium Bromide | 21 | 29 |
| Cromolyn Sodium | 362 | 465 | Cromolyn Sodium | 612 | 758 |
Page 14
K242354 510(k) Summary
Page 10 of 12
| Subject Device AllNEB K242354 | Predicate Device AeroEclipse II Breath Actuated Nebulizer - K053605 | Comment |
|---|
| Ultra-Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 207.5 | 8 lpm: 183 | Albuterol Sulfate | 5 lpm: 414.9 | 8 lpm: 389 |
| Ipratropium Bromide | 32.7 | 30 | Ipratropium Bromide | 62.4 | 72 |
| Cromolyn Sodium | 723.1 | 673 | Cromolyn Sodium | 1551.7 | 1786 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Ipratropium Bromide | 32.7 | 30 | Ipratropium Bromide | 62.4 | 72 |
| Cromolyn Sodium | 723.1 | 673 | Cromolyn Sodium | 1551.7 | 1786 |
| Fine Particle Dose (4.7 um) | |||||
|---|---|---|---|---|---|
| Albuterol Sulfate | 5 lpm: 99 | 8 lpm: 87 | 5 lpm: 207 | 8 lpm: 206 | |
| Ipratropium Bromide | 15 | 14 | Ipratropium Bromide | 36 | 27 |
| Cromolyn Sodium | 418 | 346 | Cromolyn Sodium | 838 | 846 |
| **Fine Particle Dose (