FDA product code BTL: Ventilator, Emergency, Powered (Resuscitator)
BTL is the FDA product code for ventilator, emergency, powered (resuscitator). It is a Class II device, regulated under 21 CFR 868.5925 and reviewed by the Anesthesiology panel. FDA has cleared 100 510(k) submissions under BTL, 2 in the last five years, from 46 different applicants. The average 510(k) review took 156 days (median 128); 203 days on average over the last three years. FDA has posted 29 recalls for BTL devices, 8 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, Emergency, Powered (Resuscitator) |
| Device class | Class II |
| Regulation | 21 CFR 868.5925 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
510(k) clearances per year for BTL
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 2 | 274 |
| 2018 | 1 | 385 |
| 2019 | 1 | 86 |
| 2020 | 1 | 367 |
| 2021 | 1 | 189 |
| 2023 | 1 | 352 |
| 2025 | 1 | 203 |
Compare with all 510(k) review times · Search every BTL clearance
Top BTL applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Allied Healthcare Products, Inc. | 9 | 2014-04-09 |
| Pneupac , Ltd. | 8 | 2004-05-27 |
| Life Support Products, Inc. | 8 | 1995-01-09 |
| O-Two Systems Intl., Inc. | 7 | 1999-04-22 |
| Vortran Medical Technology 1, Inc. | 6 | 2021-02-11 |
41 more applicants have BTL clearances. See the full list in Caduvo.
Most recent BTL clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K242769 | Draegerwerk AG & CO Kgaa | VentStar Resus heated (N) (MP17030); VentStar Autobreath heated (N) (MP17031) | 2025-04-04 | 203 |
| K221634 | Magnamed Tecnologia Medica S/A | Oxymag - Transport and Emergency Ventilator | 2023-05-24 | 352 |
| K202219 | Vortran Medical Technology 1, Inc. | VORTRAN GO2VENT with PEEP Valve | 2021-02-11 | 189 |
| K193191 | Weinmann Emergency Medical Technology GmbH + Co. KG | MEDUMAT Easy CPR, MEDUMAT Easy CPR with bag | 2020-11-20 | 367 |
| K182956 | International Biomedical | Puffin Lite Infant Resuscitation System | 2019-01-18 | 86 |
Recalls for BTL devices
29 product recalls in 20 recall events; 8 initiated in the last five years and 9 still open. Most recent: 2024-12-10.
| Year | Recalls |
|---|---|
| 2017 | 2 |
| 2019 | 3 |
| 2020 | 1 |
| 2021 | 1 |
| 2024 | 8 |
Frequently asked questions
What is FDA product code BTL?
BTL is the FDA product code for ventilator, emergency, powered (resuscitator). It is a Class II device, regulated under 21 CFR 868.5925 and reviewed by the Anesthesiology panel.
What device class is BTL?
Class II, regulation 21 CFR 868.5925. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTL?
Across 100 cleared submissions the average was 156 days from receipt to decision (median 128).
Which companies have the most BTL clearances?
Allied Healthcare Products, Inc. (9); Pneupac , Ltd. (8); Life Support Products, Inc. (8); O-Two Systems Intl., Inc. (7); Vortran Medical Technology 1, Inc. (6).
Have BTL devices been recalled?
Yes: 29 product recalls across 20 recall events; the most recent began 2024-12-10.
Next steps
- Run an FDA pathway report with predicate devices for product code BTL
- Run a recall and safety report across every BTL manufacturer
- Watch product code BTL for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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