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)
Top companies in CAH
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Nov 13, 2025 | Medline Industries, LP Anesthesia circuit kit;
CIRCUIT,ANES,EXTENDFLEX,120,LF
DYNJAA10230 Open, Classified |
CAH | K925217 |
| Jul 31, 2025 | Draeger, Inc. SafeStar 60A Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Jul 31, 2025 | Draeger, Inc. HME TwinStar HEPA Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Jul 31, 2025 | Draeger, Inc. SafeStar 55 Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Jul 31, 2025 | Draeger, Inc. SafeStar 90 Plus Filter. Bidirectionally breathing system filter. Open, Classified |
CAH | K221836 |
| Mar 4, 2025 | Kung Shin Plastics Co. Ltd. CircuitGuard Bacterial/Viral Filter with Elbow (Model/Catalogue number: SK200FPE / 7056) Open, Classified |
CAH | K032878 |
| Mar 4, 2025 | Kung 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 |
CAH | K032878 |
| Sep 6, 2024 | MEDLINE 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 |
CAH | K925217 |
| Aug 28, 2023 | Smiths Medical ASD Inc. PORTEX 0.5u HYDROPHOBIC DISC FILTER, REF 002291 - Bacterial/Viral filter Open, Classified |
CAH | None listed |
| Feb 22, 2023 | S & 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 |
CAH | K192713 |
| Oct 14, 2022 | TELEFLEX LLC Filter + Catheter Mount, REF 191667-000100, OUS only. Catheter mount for circuit-patient connection (Endotracheal tube and mask) Open, Classified |
CAH | K965016 |
| Oct 14, 2022 | TELEFLEX 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 |
CAH | K965016 |
| Oct 14, 2022 | TELEFLEX 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 |
CAH | K965016 |
| Oct 14, 2022 | TELEFLEX LLC Iso-Gard Filter S, Tethered Cap, REF: a) 19211T, OUS only; b) 19212T, OUS only; Microbial medical gas filter, single-use Open, Classified |
CAH | K965016 |
| Oct 14, 2022 | TELEFLEX 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 |
CAH | K965016 |
| Oct 14, 2022 | TELEFLEX 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 |
CAH | K965016 |
| May 16, 2022 | Draeger Medical, Inc. Drager SafeStar 55, Catalog No. MP01790 Open, Classified |
CAH | K072002 |
| Jun 16, 2021 | Covidien, 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 |
CAH | K941381 |
| Jun 16, 2021 | Covidien, 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 |
CAH | K941535 |
| Jun 16, 2021 | Covidien, 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 |
CAH | K941536 |
| Jun 16, 2021 | Covidien, 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 |
CAH | K941676 |
| Mar 15, 2017 | King 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 |
CAH | K973797 |
| Oct 6, 2014 | Alliance 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 |
CAH | K043148 |
| Jul 10, 2014 | Pall 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 |
CAH | K791307 |
| Jan 23, 2014 | Vital 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 |
CAH | K831856 |
| Jan 11, 2012 | A 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 |
CAH | K063526 |
| Jun 3, 2010 | Continental 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 |
CAH | K063526 |
| Jul 7, 2005 | Smiths Medical International Ltd Portex HEPA Bacterial /Viral Filter, Non-Latex
Ref: 002890 Terminated |
CAH | K930816 |
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