CAH · Class II · 21 CFR 868.5260

FDA Product Code CAH: Filter, Bacterial, Breathing-circuit

Leading manufacturers include Medipart Jerry Alexander, Mallinckrodt Medical and Vital Signs, Inc..

202
Total
202
Cleared
127d
Avg days
1976
Since
Declining activity - 3 submissions in the last 2 years vs 6 in the prior period
Review times increasing: avg 265d recently vs 125d historically

FDA 510(k) Cleared Filter, Bacterial, Breathing-circuit Devices (Product Code CAH)

202 devices
1–24 of 202
Cleared May 15, 2026
Iso-Gard Filter Straight
K252643
Teleflex Medical Sdn. Bhd.
General Hospital · 267d
Cleared Apr 30, 2026
Ambu® Virobac II® Exhalation Filter
K251583
Ambu A/S
General Hospital · 342d
Cleared Nov 14, 2024
Besmed Bacterial Filter and HMEF
K241339
Besmed Health Business Corp
General Hospital · 185d
Cleared Feb 15, 2024
Breathing circuit bacterial/viral filter
K222917
Shaoxing Haitech Medical Products Co., Ltd.
General Hospital · 507d
Cleared Sep 16, 2023
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
K230483
Passy-Muir, Inc.
General Hospital · 205d
Cleared Jun 15, 2023
TNI Clear-Guard™ 3 angled breathing filter (1545020)
K223258
Intersurgical , Ltd.
General Hospital · 237d
Cleared Feb 08, 2023
Filter and HME/Filter
K221472
Ningbo Huakun Medical Equipment Co., Ltd.
General Hospital · 264d
Cleared Dec 07, 2022
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
K221836
Dr?gerwerk AG & Co KGaA
General Hospital · 167d
Cleared Nov 22, 2022
EasyOne Filter
K221250
Ndd Medizintechnik AG
General Hospital · 204d
Cleared Mar 27, 2022
GGM Breathing Circuit Bacterial Filter
K210352
Great Group Medical Co, Ltd.
General Hospital · 412d
Cleared Nov 16, 2021
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
K211286
Pall Corporation
General Hospital · 203d
Cleared Sep 26, 2021
Bact-Trap Filter, Bact-Trap Mini, Bact-Trap Midi, Pharma Mini HME/Filter, Bact-HME HME/Filter and Bact-HME Midi HME/Filter
K202459
Pharma System AB
General Hospital · 395d
Cleared Mar 23, 2020
HepaShield Bacterial Viral Breathing System Filter
K191909
Flexicare Medical Limited.
General Hospital · 250d
Cleared Mar 16, 2020
Altera Filter and HME/Filter
K192713
Meditera Tibbi Malzeme San VE Tic AS
General Hospital · 171d
Cleared Oct 21, 2019
Servo Guard
K182862
Maquet Critical Care AB
General Hospital · 375d
Cleared Sep 25, 2019
SafeBreath Filter Mouthpiece
K190022
MD Diagnostics Limited
General Hospital · 264d
Cleared Feb 05, 2014
RT016 INSPIRATORY FILTER
K133666
Fisher &Paykel Healthcare , Ltd.
General Hospital · 68d
Cleared Sep 21, 2012
HUMID-VENT HEPA
K112958
Teleflex Medical
General Hospital · 352d
Cleared Aug 01, 2005
RT019 INSPIRATORY/EXPIRATORY FILTER
K050927
Fisher &Paykel Healthcare , Ltd.
General Hospital · 110d
Cleared Mar 01, 2005
MIN-FILTER/S, UNI-FILTER JUNIOR, UNI-FILTER/S ANGLED AND UNI-FILTER
K043120
Datex-Ohmeda, Inc.
General Hospital · 109d
Cleared Jun 25, 2003
DATEX-OHMEDA MINI-FILTER/S AND UNI-FILTER JUNIOR
K030990
Datex-Ohmeda
General Hospital · 89d
Cleared Jun 20, 2003
DATEX-OHMEDA HMEF 750
K031653
Datex-Ohmeda
General Hospital · 23d
Cleared Nov 27, 2002
DATEX-OHMEDA HMEF MINI
K023641
Datex-Ohmeda
General Hospital · 28d
Cleared Aug 30, 2002
DATEX-OHMEDA HMEF 500
K021265
Datex-Ohmeda
General Hospital · 130d

About Product Code CAH - Regulatory Context

510(k) Submission Activity

202 total 510(k) submissions under product code CAH since 1976, with 202 receiving FDA clearance (average review time: 127 days).

Submission volume has declined in recent years - 3 submissions in the last 24 months compared to 6 in the prior period.

FDA 510(k) Review Time - CAH Product Code

Recent submissions under CAH have taken an average of 265 days to reach a decision - up from 125 days historically. Manufacturers should account for longer review timelines in current project planning.

CAH devices are reviewed by the General Hospital panel. Browse all General Hospital devices →