FDA Product Code CAH: Filter, Bacterial, Breathing-circuit
Leading manufacturers include Intersurgical , Ltd., Passy-Muir, Inc. and Besmed Health Business Corp.
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
Cleared
May 15, 2026
Iso-Gard Filter Straight
Teleflex Medical Sdn. Bhd.
General Hospital
267d
Cleared
Apr 30, 2026
Ambu® Virobac II® Exhalation Filter
Ambu A/S
General Hospital
342d
Cleared
Nov 14, 2024
Besmed Bacterial Filter and HMEF
Besmed Health Business Corp
General Hospital
185d
Cleared
Feb 15, 2024
Breathing circuit bacterial/viral filter
Shaoxing Haitech Medical Products Co., Ltd.
General Hospital
507d
Cleared
Sep 16, 2023
Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15)
Passy-Muir, Inc.
General Hospital
205d
Cleared
Jun 15, 2023
TNI Clear-Guard™ 3 angled breathing filter (1545020)
Intersurgical , Ltd.
General Hospital
237d
Cleared
Feb 08, 2023
Filter and HME/Filter
Ningbo Huakun Medical Equipment Co., Ltd.
General Hospital
264d
Cleared
Dec 07, 2022
Filter CareStar Plus, Filter SafeStar Plus, Filter/HME TwinStar Plus
Dr?gerwerk AG & Co KGaA
General Hospital
167d
Cleared
Nov 22, 2022
EasyOne Filter
Ndd Medizintechnik AG
General Hospital
204d
Cleared
Mar 27, 2022
GGM Breathing Circuit Bacterial Filter
Great Group Medical Co, Ltd.
General Hospital
412d
Cleared
Nov 16, 2021
Ultipor U55/U55N Breathing Circuit Filter and Heat and Moisture Exchanger
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
Pharma System AB
General Hospital
395d
Cleared
Mar 23, 2020
HepaShield Bacterial Viral Breathing System Filter
Flexicare Medical Limited.
General Hospital
250d
Cleared
Mar 16, 2020
Altera Filter and HME/Filter
Meditera Tibbi Malzeme San VE Tic AS
General Hospital
171d
Cleared
Oct 21, 2019
Servo Guard
Maquet Critical Care AB
General Hospital
375d
Cleared
Sep 25, 2019
SafeBreath Filter Mouthpiece
MD Diagnostics Limited
General Hospital
264d
Cleared
Jan 26, 1993
MERIDIAN MEDICAL SYSTEMS BREATHING FILTER
Merit Medical Systems, Inc.
General Hospital
102d
Cleared
Sep 21, 1976
3M BRAND ANESTHESIA FILTER,#3110
3M Company
General Hospital
11d
Cleared
Jul 16, 1976
FILTER, RESPIRATORY (U-MID)
Bd Becton Dickinson Vacutainer Systems Preanalytic
General Hospital
31d
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 →