Data / Medical devices / Filter, Bacterial, Breathing-Circuit / United States
FDA-registered makers of Filter, Bacterial, Breathing-Circuit in the United States: 23 establishments
23 establishments in the United States are registered with the FDA to make Filter, Bacterial, Breathing-Circuit (product code CAH). 17 have a 510(k) clearance or PMA approval on file and 4 have a recall event. FDA data exported November 2, 2026.
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- Device
- Filter, Bacterial, Breathing-Circuit
- Product code
- CAH
- Country
- United States
Makers of Filter, Bacterial, Breathing-Circuit in the United States
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| SunMed Group Holdings, LLC | Grand Rapids, MI, United States | Complaint file establishment, Specification developer | 15 | December 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Icu Medical, Inc. | San Clemente, CA, United States | Complaint file establishment, Specification developer | 7 | May 13, 2004 | 0 | 0 | 0 | api.fda.gov |
| Teleflex Medical LLC | Morrisville, NC, United States | Complaint file establishment, Specification developer | 7 | September 21, 2012 | 0 | 1 | 1 | api.fda.gov |
| Covidien | Lafayette, CO, United States | Specification developer | 5 | November 26, 1996 | 0 | 0 | 0 | api.fda.gov |
| Pentair Filtration Solutions | Saint Paul, MN, United States | Contract manufacturer, Manufacturer | 5 | June 5, 2006 | 0 | 0 | 0 | api.fda.gov |
| A-M Systems | Sequim, WA, United States | Manufacturer | 4 | November 22, 2022 | 0 | 1 | 0 | api.fda.gov |
| Westmed, Inc. | Tucson, AZ, United States | Contract manufacturer, Manufacturer | 4 | December 6, 2012 | 0 | 0 | 0 | api.fda.gov |
| Global Life Sciences Solutions USA LLC | Marlborough, MA, United States | Complaint file establishment, Specification developer | 3 | November 16, 2021 | 0 | 0 | 0 | api.fda.gov |
| King Systems Corporation. | Noblesville, IN, United States | Manufacturer, Repackager or relabeler, Specification developer | 3 | March 1, 1999 | 0 | 1 | 0 | api.fda.gov |
| AG Industries LLC | Fairburn, GA, United States | Manufacturer | 1 | February 4, 2010 | 0 | 0 | 0 | api.fda.gov |
| Alliance Tech Medical, Inc. | Granbury, TX, United States | Repackager or relabeler, Specification developer | 1 | December 13, 2004 | 0 | 1 | 0 | api.fda.gov |
| Allied Medical LLC | Earth City, MO, United States | Specification developer | 1 | December 14, 2005 | 0 | 0 | 0 | api.fda.gov |
| Covidien | Carlsbad, CA, United States | Specification developer | 1 | July 7, 1995 | 0 | 0 | 0 | api.fda.gov |
| Intersurgical Inc. | Indianapolis, IN, United States | Manufacturer, Specification developer | 1 | April 19, 2002 | 0 | 0 | 0 | api.fda.gov |
| Mercury Medical Enterprises, LLC | Clearwater, FL, United States | Manufacturer | 1 | October 3, 1996 | 0 | 0 | 0 | api.fda.gov |
| Passy-Muir, Inc. | Irvine, CA, United States | Manufacturer, Specification developer | 1 | September 16, 2023 | 0 | 0 | 0 | api.fda.gov |
| Sdi Diagnostics, Inc. | South Easton, MA, United States | Manufacturer | 1 | October 21, 1993 | 0 | 0 | 0 | api.fda.gov |
| Exceleron Medical, LLC | Saint Paul, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| ICU Medical, Inc. | Dublin, OH, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Intechrity Inc | Irvine, CA, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Mirion Technologies (capintec), Inc | Florham Park, NJ, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Woodinville, WA, United States | Manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ventec Life Systems, Inc. | Bothell, WA, United States | Complaint file establishment, Manufacturer, Specification developer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 2, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.