Browse hierarchy: [Anesthesiology (AN)](/submissions/AN) → [Subpart F — Therapeutic Devices](/submissions/AN/subpart-f%E2%80%94therapeutic-devices) → [21 CFR 868.5260](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5260) → CAH — Filter, Bacterial, Breathing-Circuit # CAH · Filter, Bacterial, Breathing-Circuit _Anesthesiology · 21 CFR 868.5260 · Class 2_ **Canonical URL:** https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH ## Overview - **Product Code:** CAH - **Device Name:** Filter, Bacterial, Breathing-Circuit - **Regulation:** [21 CFR 868.5260](/submissions/AN/subpart-f%E2%80%94therapeutic-devices/868.5260) - **Device Class:** 2 - **Review Panel:** [Anesthesiology](/submissions/AN) - **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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K241339.md) | Besmed Bacterial Filter and HMEF | Besmed Health Business Corp | Nov 14, 2024 | SESE | | [K222917](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K222917.md) | Breathing circuit bacterial/viral filter | Shaoxing Haitech Medical Products Co., Ltd. | Feb 15, 2024 | SESE | | [K230483](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K230483.md) | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | Passy-Muir, Inc. | Sep 16, 2023 | SESE | | [K223258](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K223258.md) | TNI Clear-Guard™ 3 angled breathing filter (1545020) | Intersurgical , Ltd. | Jun 15, 2023 | SESE | | [K221472](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K221472.md) | Filter and HME/Filter | Ningbo Huakun Medical Equipment Co., Ltd. | Feb 8, 2023 | SESE | | [K221836](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K221836.md) | Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus | Drägerwerk AG & Co. KGaA | Dec 7, 2022 | SESE | | [K221250](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K221250.md) | EasyOne Filter | Ndd Medizintechnik AG | Nov 22, 2022 | SESE | | [K210352](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K210352.md) | GGM Breathing Circuit Bacterial Filter | Great Group Medical Co, Ltd. | Mar 27, 2022 | SESE | | [K211286](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K211286.md) | Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger | Pall Corporation | Nov 16, 2021 | SESE | | [K202459](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K202459.md) | 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](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K191909.md) | HepaShield Bacterial Viral Breathing System Filter | Flexicare Medical Limited. | Mar 23, 2020 | SESE | | [K192713](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K192713.md) | Altera Filter and HME/Filter | Meditera Tibbi Malzeme San VE Tic AS | Mar 16, 2020 | SESE | | [K182862](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K182862.md) | Servo Guard | Maquet Critical Care AB | Oct 21, 2019 | SESE | | [K190022](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K190022.md) | SafeBreath Filter Mouthpiece | MD Diagnostics Limited | Sep 25, 2019 | SESE | | [K163300](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K163300.md) | ThermoShield HME Filter | Flexicare Medical Limited. | Mar 22, 2017 | SESE | | [K151498](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K151498.md) | Breathing circuit bacterial/viral filter | Zhejiang Haisheng Medical Device Co., Ltd. | Dec 18, 2015 | SESE | | [K141087](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K141087.md) | INTER-THERM PEDIATRIC HMEF, INTERN-THERM MINI PEDIATRIC ANGLED HMEF | Intersurgical Incorporated | Feb 12, 2015 | SESE | | [K132709](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K132709.md) | VR MEDICAL HEAT AND MOISTURE EXCHANGER AND FILTER | Vr Medical | Jul 30, 2014 | SESE | | [K132679](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K132679.md) | AF VIRAL/BACTERIAL FILTER, BF VIRAL/BACTERIAL FILTER | Galemed Corp. | Apr 18, 2014 | SESE | | [K131626](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH/K131626.md) | 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 --- **Source:** [https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH](https://fda.innolitics.com/submissions/AN/subpart-f%E2%80%94therapeutic-devices/CAH) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. 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