CAH · Filter, Bacterial, Breathing-Circuit
Anesthesiology · 21 CFR 868.5260 · Class 2
Overview
| Product Code | CAH |
|---|---|
| Device Name | Filter, Bacterial, Breathing-Circuit |
| Regulation | 21 CFR 868.5260 |
| Device Class | Class 2 |
| Review Panel | Anesthesiology |
| 3rd-Party Reviewable | Yes |
Identification
A breathing circuit bacterial filter is a device that is intended to remove microbiological and particulate matter from the gases in the breathing circuit.
Classification Rationale
Class II (performance standards).
Recent Cleared Devices (20 of 200)
Showing 20 most recent of 200 cleared devices.
| Record | Device Name | Applicant | Decision Date | Decision |
|---|---|---|---|---|
| K241339 | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | Nov 14, 2024 | SESE |
| K222917 | Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd. | Feb 15, 2024 | SESE |
| K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | Sep 16, 2023 | SESE |
| K223258 | TNI Clear-Guard 3 angled breathing filter (1545020) | Intersurgical , Ltd. | Jun 15, 2023 | SESE |
| K221472 | Filter and HME/Filter | Ningbo Huakun Medical Equipment Co., Ltd. | Feb 8, 2023 | SESE |
| K221836 | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | Dec 7, 2022 | SESE |
| K221250 | EasyOne Filter | Ndd Medizintechnik AG | Nov 22, 2022 | SESE |
| K210352 | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | Mar 27, 2022 | SESE |
| K211286 | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | Pall Corporation | Nov 16, 2021 | SESE |
| 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 | Sep 26, 2021 | SESE |
| K191909 | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | Mar 23, 2020 | SESE |
| K192713 | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS | Mar 16, 2020 | SESE |
| K182862 | Servo Guard | Maquet Critical Care AB | Oct 21, 2019 | SESE |
| K190022 | SafeBreath Filter Mouthpiece | MD Diagnostics Limited | Sep 25, 2019 | SESE |
| K163300 | ThermoShield HME Filter | Flexicare Medical Limited. | Mar 22, 2017 | SESE |
| K151498 | Breathing circuit bacterial/viral filter | Zhejiang Haisheng Medical Device Co., Ltd. | Dec 18, 2015 | SESE |
| K141087 | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF | Intersurgical Incorporated | Feb 12, 2015 | SESE |
| K132709 | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | Vr Medical | Jul 30, 2014 | SESE |
| K132679 | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | Galemed Corp. | Apr 18, 2014 | SESE |
| K131626 | EXCELERON BACTERIAL FILTERS | Exceleron Medical | Feb 26, 2014 | SESE |
Top Applicants
- Intersurgical, Inc. — 9 clearances
- Medipart Jerry Alexander — 8 clearances
- Porous Media Corp. — 6 clearances
- King Systems Corp. — 5 clearances
- Mallinckrodt Medical — 5 clearances
