Product code CAH
- Device name
- Filter, Bacterial, Breathing-Circuit
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5260
- Review panel
- HO
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K252643 | Iso-Gard Filter Straight; Humid-Vent Filter Compact Angled | Teleflex Medical Sdn. Bhd. | 2026-05-15 |
| K251583 | Ambu® Virobac II® Exhalation Filter | Ambu A/S | 2026-04-30 |
| K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | 2024-11-14 |
| K222917 | Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd. | 2024-02-15 |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | 2023-09-16 |
| K223258 | TNI Clear-Guard™ 3 angled breathing filter (1545020) | Intersurgical , Ltd. | 2023-06-15 |
| K221472 | Filter and HME/Filter | Ningbo Huakun Medical Equipment Co., Ltd. | 2023-02-08 |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | 2022-12-07 |
| K221250 | EasyOne Filter | Ndd Medizintechnik AG | 2022-11-22 |
| K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | 2022-03-27 |
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | Pall Corporation | 2021-11-16 |
| K202459 | Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter | Pharma System AB | 2021-09-26 |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | 2020-03-23 |
| K192713 | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS | 2020-03-16 |
| K182862 | Servo Guard | Maquet Critical Care AB | 2019-10-21 |
| K190022 | SafeBreath Filter Mouthpiece | MD Diagnostics Limited | 2019-09-25 |
| K163300 | ThermoShield HME Filter | Flexicare Medical Limited. | 2017-03-22 |
| K151498 | Breathing circuit bacterial/viral filter | Zhejiang Haisheng Medical Device Co., Ltd. | 2015-12-18 |
| K141087 | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF | Intersurgical Incorporated | 2015-02-12 |
| K132709 | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | Vr Medical | 2014-07-30 |
| K132679 | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | Galemed Corp. | 2014-04-18 |
| K131626 | EXCELERON BACTERIAL FILTERS | Exceleron Medical | 2014-02-26 |
| K133666 | RT016 INSPIRATORY FILTER | Fisher & Paykel Healthcare, Ltd. | 2014-02-05 |
| K130664 | HYRDROMAX HMEF | A-M Systems | 2013-06-21 |
| K121382 | WESTMED, INC.'S BLOCKAIDE FILTER [21 CFR 807.87(A)] | Westmed, Inc. | 2012-12-06 |
| K121026 | FLO-GUARD BREATHING FILTER | Intersurgical, Inc. | 2012-11-02 |
| K112958 | HUMID-VENT HEPA | Teleflex Medical | 2012-09-21 |
| K110246 | MEDISIZE RED AND MEDISIZE BLUE | Qserve America, Inc. | 2011-11-04 |
| K111408 | MICROGARD II | Carefusion Germany 234 GmbH | 2011-10-17 |
| K102483 | SUNSET HEALTHCARE SOLUTIONS BACTERIAL/VIRAL HME FILTER, MODEL BHF 104 | Sunset Healthcare Solutions, LLC | 2011-09-13 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 08697645018150 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2026-04-17 |
| 08697645018167 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2026-04-17 |
| 08697645018174 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2026-04-17 |
| 08697645018181 | ENDURE INDUSTRIES | ENDURE INDUSTRIES | 2026-04-17 |
| 07640142190899 | EasyOne Filter FT | NDD Medizintechnik AG | 2022-12-09 |
| 07640142190882 | EasyOne Filter SP | NDD Medizintechnik AG | 2022-12-09 |
| 09420012432339 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2022-08-02 |
| 08717146000505 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000017 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000635 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000628 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000581 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000574 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000567 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000550 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000529 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000512 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000024 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000499 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000451 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000444 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000437 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000086 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000079 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000062 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000055 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000048 | Medisize® | Medisize B.V. | 2016-10-07 |
| 08717146000031 | Medisize® | Medisize B.V. | 2016-10-07 |
| 09420012432315 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |
| 09420012432322 | Fisher & Paykel Healthcare | FISHER & PAYKEL HEALTHCARE LIMITED | 2016-09-08 |