ClearanceBrief
Panels › Anesthesiology › Product code CAH · Class 2

Filter, Bacterial, Breathing-Circuit

Regulation 868.5260

2510(k)s in 12 months (202 all time)
1recalls in 12 months (28 all time)
27recalls that name a 510(k)
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Top companies in CAH

DateFirm and productCodeLinked 510(k)
Nov 13, 2025Medline Industries, LP
Anesthesia circuit kit; CIRCUIT,ANES,EXTENDFLEX,120,LF DYNJAA10230
Open, Classified
CAHK925217
Jul 31, 2025Draeger, Inc.
SafeStar 60A Plus Filter. Bidirectionally breathing system filter.
Open, Classified
CAHK221836
Jul 31, 2025Draeger, Inc.
HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter.
Open, Classified
CAHK221836
Jul 31, 2025Draeger, Inc.
SafeStar 55 Plus Filter. Bidirectionally breathing system filter.
Open, Classified
CAHK221836
Jul 31, 2025Draeger, Inc.
SafeStar 90 Plus Filter. Bidirectionally breathing system filter.
Open, Classified
CAHK221836
Mar 4, 2025Kung Shin Plastics Co. Ltd.
CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056)
Open, Classified
CAHK032878
Mar 4, 2025Kung Shin Plastics Co. Ltd.
CircuitGuard ThermoFlo Filter -Combined Heat and Moisture Exchanger, Bacterial Viral Filter w O2 Port and Elbow (Model/Catalogue number: SK200CPE / 6126)
Open, Classified
CAHK032878
Sep 6, 2024MEDLINE INDUSTRIES, LP - Northfield
Medline Convenience kits labeled as: 1) FILTER-.8 MICRON, Pack Number 2008; 2) ANES CIRCUIT 90IN EXP-LF, Pack Number DYNJAA10295A
Open, Classified
CAHK925217
Aug 28, 2023Smiths Medical ASD Inc.
PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter
Open, Classified
CAHNone listed
Feb 22, 2023S & MOHR AMERICA, S.A. DE C.V.
abm Respiratory Care Standart Breating Circuit with Face Mask - Toddler REF BC21087 abm Respiratory Care Standart Breathing Circuit with Face Mask - Child/Adult Small REF BC21088 abm Respiratory Car
Open, Classified
CAHK192713
Oct 14, 2022TELEFLEX LLC
Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask)
Open, Classified
CAHK965016
Oct 14, 2022TELEFLEX LLC
Iso-Gard Filter S with Expandi-Flex/Elbow: a) REF 19012, OUS only, b) REF 19012T with Tethered Cap, OUS only; Microbial medical gas filter, single-use
Open, Classified
CAHK965016
Oct 14, 2022TELEFLEX LLC
Iso-Gard Filter S, with Expandi-Flex, Tethered Cap, REF: a) 19261T, OUS only; b) 19262T, OUS only; c) 19272T, OUS only; Microbial medical gas filter, single-use,
Open, Classified
CAHK965016
Oct 14, 2022TELEFLEX LLC
Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use
Open, Classified
CAHK965016
Oct 14, 2022TELEFLEX LLC
Iso-Gard Filter S, with Expandi-Flex, REF: a) 19261, OUS only; b) 19272, OUS only; Microbial medical gas filter, single-use
Open, Classified
CAHK965016
Oct 14, 2022TELEFLEX LLC
Iso-Gard Filter S, REF : a) 19211, OUS only; b) 19212; Microbial medical gas filter, single-use. Bacterial/viral filters for use in breathing system for the protection of patient and equipment.
Open, Classified
CAHK965016
May 16, 2022Draeger Medical, Inc.
Drager SafeStar 55, Catalog No. MP01790
Open, Classified
CAHK072002
Jun 16, 2021Covidien, LP
HME for Tracheostomized Patients, Item Code 353S13046 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard
Open, Classified
CAHK941381
Jun 16, 2021Covidien, LP
Adult-Pediatric Electrostatic Filter HME, Item Code 352/5877Z - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO
Open, Classified
CAHK941535
Jun 16, 2021Covidien, LP
Mechanical Filter with Connector Small, Tethered Cap, Item Code 351/5979 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circui
Open, Classified
CAHK941536
Jun 16, 2021Covidien, LP
Electrostatic Filter Angled, Item Code 350S19006 - Product Usage: indicated for single use on anesthetized patients and respiratory care patients who require a breathing circuit with ISO standard 15mm
Open, Classified
CAHK941676
Mar 15, 2017King Systems Corp. dba Ambu, Inc.
UNIVERSAL FLEX2 BREATHING CIRCUIT, Item Numbers: D460-6133Z, D390-6121Z, D390-6121Z, D495-61Z, DF4116-6121Z, D466-61Z, DFP170-6121, DF3115-6121Z, DF375-6121Z, DF3115-6121Z, DF3115-6121Z, D360-8031Z, D
Terminated
CAHK973797
Oct 6, 2014Alliance Tech Medical, Inc
Alliance Tech Medical, Inc. All Flow Pulmonary Function Filters, 100 filters individually packaged in a clear, sealed bag printed with the part number, 100 filters/box, for single patient use, latex f
Completed
CAHK043148
Jul 10, 2014Pall Corporation
PALL Medical Breathing Circuit Filter, REF BB50T and BB50T-BULK , Rx ONLY Single use, bi-directional bacterial/viral removal filter. The filters are individually packaged in a clear, plastic pouch
Terminated
CAHK791307
Jan 23, 2014Vital Signs Colorado Inc.
Vital Signs Anesthesia Circuits The Ventilator Circuit is intended for use as an interface between a ventilator dependent patient and a ventilator. The Anesthesia Circuit is intended to administer me
Terminated
CAHK831856
Jan 11, 2012A M Systems Inc
ViroMax viral/bacterial filter. The filter reduces the risk of infection due to cross-contamination between patients For use on all patient populations in conjunction with other respiratory devices co
Terminated
CAHK063526
Jun 3, 2010Continental Medical Labs,Inc
Xenon Diagnostic Circuit Kits labeled as "Xenon Diagnostic Circuit", "Xenon Circuit", and Needleless Xenon Diagnostic Circuit" Manufactured for RAF MEDICAL, INC., (Model number's RAF2306, RAF2304, RA
Terminated
CAHK063526
Jul 7, 2005Smiths Medical International Ltd
Portex HEPA Bacterial /Viral Filter, Non-Latex Ref: 002890
Terminated
CAHK930816

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