FDA product code BTM: Ventilator, Emergency, Manual (Resuscitator)
BTM is the FDA product code for ventilator, emergency, manual (resuscitator). It is a Class II device, regulated under 21 CFR 868.5915 and reviewed by the Anesthesiology panel. FDA has cleared 209 510(k) submissions under BTM, 4 in the last five years, from 113 different applicants. The average 510(k) review took 124 days (median 87); 155 days on average over the last three years. FDA has posted 97 recalls for BTM devices, 21 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Ventilator, Emergency, Manual (Resuscitator) |
| Device class | Class II |
| Regulation | 21 CFR 868.5915 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Life-sustaining or supporting | Yes |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BTM
| Year | Clearances | Avg. review days |
|---|---|---|
| 2018 | 2 | 303 |
| 2021 | 1 | 205 |
| 2022 | 1 | 339 |
| 2023 | 1 | 267 |
| 2025 | 2 | 155 |
Compare with all 510(k) review times · Search every BTM clearance
Top BTM applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Ambu, Inc. | 15 | 2004-11-15 |
| Puritan Bennett Corp. | 12 | 1994-12-12 |
| Medical Marketing Concepts | 11 | 1998-09-18 |
| Life Design Systems, Inc. | 7 | 1992-12-01 |
| Engineered Medical Systems | 6 | 1999-07-06 |
108 more applicants have BTM clearances. See the full list in Caduvo.
Most recent BTM clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K251631 | Laerdal Medical AS | The BAG manual resuscitator and accessories | 2025-11-24 | 180 |
| K243861 | Compact Medical, Inc. | butterflyBVM | 2025-04-25 | 130 |
| K221841 | Archeon | EOlife® | 2023-03-18 | 267 |
| K212905 | Safe Bvm Corporation | Sotair Device | 2022-08-18 | 339 |
| K210288 | Xiamen Compower Medical Tech. Co., Ltd. | Disposable Manual Resuscitator | 2021-08-26 | 205 |
Recalls for BTM devices
97 product recalls in 22 recall events; 21 initiated in the last five years and 21 still open. Most recent: 2026-05-08.
| Year | Recalls |
|---|---|
| 2018 | 16 |
| 2023 | 9 |
| 2024 | 9 |
| 2025 | 2 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code BTM?
BTM is the FDA product code for ventilator, emergency, manual (resuscitator). It is a Class II device, regulated under 21 CFR 868.5915 and reviewed by the Anesthesiology panel.
What device class is BTM?
Class II, regulation 21 CFR 868.5915. Typical premarket route: 510(k).
How long does a 510(k) take for product code BTM?
Across 209 cleared submissions the average was 124 days from receipt to decision (median 87).
Which companies have the most BTM clearances?
Ambu, Inc. (15); Puritan Bennett Corp. (12); Medical Marketing Concepts (11); Life Design Systems, Inc. (7); Engineered Medical Systems (6).
Have BTM devices been recalled?
Yes: 97 product recalls across 22 recall events; the most recent began 2026-05-08.
Next steps
- Run an FDA pathway report with predicate devices for product code BTM
- Run a recall and safety report across every BTM manufacturer
- Watch product code BTM 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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