Product code CAW: 510(k) clearances and predicates
Product code CAW covers Portable Oxygen Concentrator (OX-1A-E, OX-1B). FDA lists 289 clearances under this code in the 510(k) index. This page summarizes recent clearance volume and names recent clearances by K number so you can pick predicates faster.
Clearance volume
289 clearances on file under product code CAW. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 8 |
| 2024 | 2 |
| 2025 | 12 |
| 2026 so far | 6 |
Recent clearances
Newest CAW clearances in the FDA index, with applicant and decision date:
- K254289, Portable Oxygen Concentrator (OX-1A-E, OX-1B), applicant Oxytek Medical Technology Co., Ltd., decided 2026-09-23. FDA record
- K260171, Portable Oxygen Concentrator (PO1 5B, PO1 6B), applicant BMC Medical Co., Ltd., decided 2026-08-14. FDA record
- K252399, Portable Oxygen Concentrator, applicant Honsun (Nantong) Co., Ltd., decided 2026-06-17. FDA record
- K252965, Oxygen Concentrator (OX-5A, OX-5C), applicant Oxytek Medical Technology Co., Ltd., decided 2026-05-29. FDA record
- K252407, OxyGo Portable Oxygen Concentrator (1400-7000), applicant Mv Life, LLC, decided 2026-04-23. FDA record
- K253549, DeVilbiss 5 Liter Oxygen Concentrator (555), applicant Devilbiss Healthcare, LLC, decided 2026-03-26. FDA record
- K251534, Oxygen Concentrator (J10A), applicant Foshan Kycare Medical Equipment Co., Ltd., decided 2025-12-29. FDA record
- K251764, Oxygen Concentrator-P2-O5E, applicant Qingdao Kingon Medical Science and Technology Co., Ltd., decided 2025-12-22. FDA record
What this means for a regulatory watcher
Volume tells you how deep the predicate pool is. A code with steady yearly counts gives you many candidate predicates, which helps when one predicate has a recall or design gap. A code with a sharp recent rise means reviewers are seeing more of this device type, so substantial equivalence arguments need to track the newest cleared devices, not five year old ones. Related device names in recent clearances include Portable Oxygen Concentrator (PO1 5B, PO1 6B), Portable Oxygen Concentrator. Watch new CAW clearances as they post: each one is a possible predicate for your submission and a possible competitor worth reading.
FAQ
What is FDA product code CAW?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CAW clearances include Portable Oxygen Concentrator (OX-1A-E, OX-1B).
How many 510(k) clearances use product code CAW?
289 at the time this page was generated, from openFDA records.
How do I find a predicate device under CAW?
Start with the recent K numbers listed above, then run the free predicate search to check substantial equivalence text and review history.
How do I track new CAW clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.