Product code CAF: 510(k) clearances and predicates
Product code CAF covers Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210). FDA lists 509 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
509 clearances on file under product code CAF. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 4 |
| 2023 | 8 |
| 2024 | 4 |
| 2025 | 7 |
| 2026 so far | 2 |
Recent clearances
Newest CAF clearances in the FDA index, with applicant and decision date:
- K254171, Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210), applicant Shenzhen Mericonn Technology Co., Ltd., decided 2026-09-18. FDA record
- K260270, FindAir ONE for pMDI (FAO-MDI-V12-GRE-001), applicant FindAir Sp. z o.o., decided 2026-06-02. FDA record
- K251572, eRapid with eTrack System, applicant Pari Respiratory Equipment, Inc., decided 2025-12-19. FDA record
- K251659, Mesh Nebulizer (H6), applicant Qingdao Future Medical Technology Co., Ltd., decided 2025-11-14. FDA record
- K244035, Portable mesh nebulizer (JM821), applicant Shenzhen Jermei Medical Device Technology Co., Ltd., decided 2025-09-19. FDA record
- K243468, Compressor Nebulizer (NB-1100); Compressor Nebulizer (NB-1101); Compressor Nebulizer (NB-1102); Compressor Nebulizer (NB-1103), applicant Joytech Healthcare Co. , Ltd., decided 2025-07-02. FDA record
- K250022, HeroTracker Sense, applicant Voluntis, decided 2025-06-30. FDA record
- K250583, AdheResp Smart Breath-actuated Mesh Nebulizer, applicant Hcmed Innovations Co., Ltd., decided 2025-06-20. 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 FindAir ONE for pMDI (FAO-MDI-V12-GRE-001), eRapid with eTrack System. Watch new CAF 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 CAF?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CAF clearances include Mesh Nebulizer (UN204); Mesh Nebulizer (UN205); Mesh Nebulizer (UN209); Mesh Nebulizer (UN210).
How many 510(k) clearances use product code CAF?
509 at the time this page was generated, from openFDA records.
How do I find a predicate device under CAF?
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 CAF clearances?
Get 510(k) alerts filtered to this product code and read each new clearance as it posts.
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.