FDA product code CAW: Generator, Oxygen, Portable
CAW is the FDA product code for generator, oxygen, portable. It is a Class II device, regulated under 21 CFR 868.5440 and reviewed by the Anesthesiology panel. FDA has cleared 288 510(k) submissions under CAW, 31 in the last five years, from 152 different applicants. The average 510(k) review took 144 days (median 104); 232 days on average over the last three years. FDA has posted 44 recalls for CAW devices, 14 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Generator, Oxygen, Portable |
| Device class | Class II |
| Regulation | 21 CFR 868.5440 |
| Review panel | AN — Anesthesiology |
| Medical specialty | Anesthesiology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for CAW
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 1 | 266 |
| 2018 | 3 | 206 |
| 2019 | 2 | 203 |
| 2020 | 5 | 250 |
| 2021 | 2 | 152 |
| 2022 | 4 | 414 |
| 2023 | 8 | 340 |
| 2024 | 2 | 268 |
| 2025 | 12 | 192 |
| 2026 | 5 | 236 |
Compare with all 510(k) review times · Search every CAW clearance
Top CAW applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Invacare Corp. | 15 | 2007-12-12 |
| Mountain Medical Equipment, Inc. | 12 | 1993-01-15 |
| The John Bunn Co. | 8 | 1987-09-15 |
| Nidek Medical Products, Inc. | 7 | 2020-05-07 |
| Airsep Corp. | 7 | 2011-03-28 |
147 more applicants have CAW clearances. See the full list in Caduvo.
Most recent CAW clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260171 | BMC Medical Co., Ltd. | Portable Oxygen Concentrator (PO1 5B, PO1 6B) | 2026-08-14 | 205 |
| K252399 | Honsun (Nantong) Co., Ltd. | Portable Oxygen Concentrator | 2026-06-17 | 321 |
| K252965 | Oxytek Medical Technology Co., Ltd. | Oxygen Concentrator (OX-5A, OX-5C) | 2026-05-29 | 254 |
| K252407 | Mv Life, LLC | OxyGo Portable Oxygen Concentrator (1400-7000) | 2026-04-23 | 266 |
| K253549 | Devilbiss Healthcare, LLC | DeVilbiss 5 Liter Oxygen Concentrator (555) | 2026-03-26 | 132 |
Recalls for CAW devices
44 product recalls in 31 recall events; 14 initiated in the last five years and 9 still open. Most recent: 2026-02-04.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2019 | 2 |
| 2020 | 1 |
| 2022 | 4 |
| 2023 | 1 |
| 2024 | 5 |
| 2025 | 3 |
| 2026 | 1 |
Frequently asked questions
What is FDA product code CAW?
CAW is the FDA product code for generator, oxygen, portable. It is a Class II device, regulated under 21 CFR 868.5440 and reviewed by the Anesthesiology panel.
What device class is CAW?
Class II, regulation 21 CFR 868.5440. Typical premarket route: 510(k).
How long does a 510(k) take for product code CAW?
Across 288 cleared submissions the average was 144 days from receipt to decision (median 104).
Which companies have the most CAW clearances?
Invacare Corp. (15); Mountain Medical Equipment, Inc. (12); The John Bunn Co. (8); Nidek Medical Products, Inc. (7); Airsep Corp. (7).
Have CAW devices been recalled?
Yes: 44 product recalls across 31 recall events; the most recent began 2026-02-04.
Next steps
- Run an FDA pathway report with predicate devices for product code CAW
- Run a recall and safety report across every CAW manufacturer
- Watch product code CAW 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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