Product code CAH: 510(k) clearances and predicates
Product code CAH covers Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled. FDA lists 202 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
202 clearances on file under product code CAH. Counts by year:
| Year | Clearances |
|---|---|
| 2022 | 3 |
| 2023 | 3 |
| 2024 | 2 |
| 2025 | 0 |
| 2026 so far | 2 |
Recent clearances
Newest CAH clearances in the FDA index, with applicant and decision date:
- K252643, Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled, applicant Teleflex Medical Sdn. Bhd., decided 2026-05-15. FDA record
- K251583, Ambu® Virobac II® Exhalation Filter, applicant Ambu A/S, decided 2026-04-30. FDA record
- K241339, Besmed Bacterial Filter and HMEF, applicant Besmed Health Business Corp, decided 2024-11-14. FDA record
- K222917, Breathing circuit bacterial/viral filter, applicant Shaoxing Haitech Medical Products Co., Ltd., decided 2024-02-15. FDA record
- K230483, Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15), applicant Passy-Muir, Inc., decided 2023-09-16. FDA record
- K223258, TNI Clear-Guard 3 angled breathing filter (1545020), applicant Intersurgical , Ltd., decided 2023-06-15. FDA record
- K221472, Filter and HME/Filter, applicant Ningbo Huakun Medical Equipment Co., Ltd., decided 2023-02-08. FDA record
- K221836, Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus, applicant Drägerwerk AG & Co. KGaA, decided 2022-12-07. 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 Ambu® Virobac II® Exhalation Filter, Besmed Bacterial Filter and HMEF. Watch new CAH 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 CAH?
It is the three letter code FDA assigns to a device type in the 510(k) index. Recent CAH clearances include Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled.
How many 510(k) clearances use product code CAH?
202 at the time this page was generated, from openFDA records.
How do I find a predicate device under CAH?
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 CAH clearances?
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Data: U.S. FDA via openFDA (public domain). Not regulatory advice. Assume all results are unvalidated.