CAH — Filter, Bacterial, Breathing-Circuit Class II
FDA product code CAH covers "Filter, Bacterial, Breathing-Circuit", a Class II medical device regulated under 21 CFR 868.5260. Submissions are reviewed by the Anesthesiology panel. At least 20 recent 510(k) clearances have been granted under this product code.
Classification Details
- Product Code
- CAH
- Device Class
- Class II
- Regulation Number
- 868.5260
- Submission Type
- Review Panel
- HO
- Medical Specialty
- Anesthesiology
- Implant
- No
Recent 510(k) Clearances
| K-Number | Applicant | Device Name | Date |
|---|---|---|---|
| K252643 | teleflex medical sdn. bhd | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | May 15, 2026 |
| K251583 | ambu | Ambu® Virobac II® Exhalation Filter | April 30, 2026 |
| K241339 | besmed health business | Besmed Bacterial Filter and HMEF | November 14, 2024 |
| K222917 | shaoxing haitech medical products co | Breathing circuit bacterial/viral filter | February 15, 2024 |
| K230483 | passy-muir | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | September 16, 2023 |
| K223258 | intersurgical | TNI Clear-Guard 3 angled breathing filter (1545020) | June 15, 2023 |
| K221472 | ningbo huakun medical equipment co | Filter and HME/Filter | February 8, 2023 |
| K221836 | drägerwerk ag and co. kgaa | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | December 7, 2022 |
| K221250 | ndd medizintechnik | EasyOne Filter | November 22, 2022 |
| K210352 | great group medical co | GGM Breathing Circuit Bacterial Filter | March 27, 2022 |
| K211286 | pall corporation | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | November 16, 2021 |
| K202459 | pharma system | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-H | September 26, 2021 |
| K191909 | flexicare medical limited | HepaShield Bacterial Viral Breathing System Filter | March 23, 2020 |
| K192713 | meditera tibbi malzeme san ve tic | Altera Filter and HME/Filter | March 16, 2020 |
| K182862 | maquet critical care | Servo Guard | October 21, 2019 |
| K190022 | md diagnostics limited | SafeBreath Filter Mouthpiece | September 25, 2019 |
| K163300 | flexicare medical limited | ThermoShield HME Filter | March 22, 2017 |
| K151498 | zhejiang haisheng medical device co | Breathing circuit bacterial/viral filter | December 18, 2015 |
| K141087 | intersurgical incorporated | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF | February 12, 2015 |
| K132709 | vr medical | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | July 30, 2014 |