CAH
- Product code
- CAH
- Device name
- Filter, Bacterial, Breathing-Circuit
- Device class
- Class 2
- 21 CFR
- 21 CFR 868.5260
- Medical specialty
- Anesthesiology
- Marketing pathway
- 510(K)
- Flag
- Third-party review eligible
- 510(k) clearances (last 3 years)
- 5
- Summaries archived here
- 4 (direct download)
- 510(k) clearances (all years, FDA)
- 202 (all years; only the last 3 years are listed here)
510(k) clearances, last 3 years (5)
| Number | Decision date | Applicant | Device name | Summary |
|---|---|---|---|---|
| K252643 | 2026-05-15 | Teleflex Medical Sdn. Bhd. | Iso-Gard Filter Straight; Humid-Vent Filter Compact | |
| K251583 | 2026-04-30 | Ambu A/S | Ambu® Virobac II® Exhalation Filter | |
| K241339 | 2024-11-14 | Besmed Health Business Corp | Besmed Bacterial Filter and HMEF | |
| K222917 | 2024-02-15 | Shaoxing Haitech Medical Products Co., | Breathing circuit bacterial/viral filter | — |
| K230483 | 2023-09-16 | Passy-Muir, Inc. | Passy Muir Tracheostomy Viral & Bacterial Airway Pro |
Official FDA classification page: CAH
Classification and pathway per current FDA publications. Data from openFDA (CC0).