FDA product code BWF: Spirometer, Therapeutic (Incentive)
BWF is the FDA product code for spirometer, therapeutic (incentive). It is a Class II device, regulated under 21 CFR 868.5690 and reviewed by the Anesthesiology panel. FDA has cleared 108 510(k) submissions under BWF, 5 in the last five years, from 76 different applicants. The average 510(k) review took 121 days (median 87); 270 days on average over the last three years. FDA has posted 1 recall for BWF devices.
Classification
| Field | Value |
|---|---|
| Device name | Spirometer, Therapeutic (Incentive) |
| Device class | Class II |
| Regulation | 21 CFR 868.5690 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for BWF
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 193 |
| 2018 | 1 | 238 |
| 2019 | 3 | 344 |
| 2020 | 1 | 208 |
| 2021 | 1 | 134 |
| 2022 | 1 | 239 |
| 2023 | 2 | 390 |
| 2024 | 1 | 59 |
| 2025 | 1 | 482 |
Compare with all 510(k) review times · Search every BWF clearance
Top BWF applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Dhd Healthcare Corp. | 5 | 2000-12-05 |
| Health Products, Inc. | 4 | 1992-01-30 |
| Dhd Medical Products Div. Diemolding Corp. | 4 | 1984-03-05 |
| Trudell Medical International | 3 | 2019-08-16 |
| Advanced Circulatory Systems, Inc. | 3 | 2007-06-20 |
71 more applicants have BWF clearances. See the full list in Caduvo.
Most recent BWF clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K241152 | Tidal Medical Technologies, LLC | InSee | 2025-08-21 | 482 |
| K233855 | Enchant Tek Co. , Ltd. | AllPEP | 2024-02-02 | 59 |
| K221058 | Lung Trainers, LLC | LungTrainer (MD2 & MD3) | 2023-07-05 | 450 |
| K222018 | Peep Medical, LLC Dba Go2 Devices | Breathe+ | 2023-06-02 | 329 |
| K220565 | Medline Industries, Inc. | Hudson RCI Triflo II Incentive Deep Breathing Exerciser | 2022-10-25 | 239 |
Recalls for BWF devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2020-12-21.
| Year | Recalls |
|---|---|
| 2020 | 1 |
Frequently asked questions
What is FDA product code BWF?
BWF is the FDA product code for spirometer, therapeutic (incentive). It is a Class II device, regulated under 21 CFR 868.5690 and reviewed by the Anesthesiology panel.
What device class is BWF?
Class II, regulation 21 CFR 868.5690. Typical premarket route: 510(k).
How long does a 510(k) take for product code BWF?
Across 108 cleared submissions the average was 121 days from receipt to decision (median 87).
Which companies have the most BWF clearances?
Dhd Healthcare Corp. (5); Health Products, Inc. (4); Dhd Medical Products Div. Diemolding Corp. (4); Trudell Medical International (3); Advanced Circulatory Systems, Inc. (3).
Have BWF devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2020-12-21.
Next steps
- Run an FDA pathway report with predicate devices for product code BWF
- Run a recall and safety report across every BWF manufacturer
- Watch product code BWF 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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