Data / Medical devices / United States / Passy-Muir, Inc.
Passy-Muir, Inc.: FDA-registered device maker in Irvine, CA, United States, 7 510(k) clearances
Passy-Muir, Inc. is registered with the FDA (registration 2024841) in Irvine, CA, United States. It lists 5 device types. The FDA files 7 510(k) clearances under its listings, the newest dated September 16, 2023. Registered through 2027. FDA data exported November 2, 2026.
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- FDA registration number
- 2024841
- Address
- 17992 Mitchell S Ste 200, Irvine, CA, United States, 92614
- Owner or operator
- PASSY-MUIR, INC. (2024841)
- Roles
- Manufacturer, Specification developer
- First device listed
- January 18, 1993
- Registered through
- 2027
- Brand names listed
- PMA 2000, PMV 005, PMV 007, PMV 2000, PMV 2001, PMV 2020, Passy Muir DigiSil Digital (Finger) Occlusion Adapter PM-OCLN, Passy Muir Heat Moisture Exchanger and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Condenser, Heat And Moisture (Artificial Nose) | BYD | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Connector, Airway (Extension) | BZA | 1 | Manufacturer, Specification developer | accessdata.fda.gov |
| Filter, Bacterial, Breathing-Circuit | CAH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tube Tracheostomy And Tube Cuff | JOH | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
| Tube, Tracheostomy (W/Wo Connector) | BTO | 2 | Manufacturer, Specification developer | accessdata.fda.gov |
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| September 16, 2023 | K230483 | Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) | CAH | Substantially Equivalent | Passy-Muir, Inc. | accessdata.fda.gov |
| June 11, 1999 | K990905 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY SPEAKING VALVE PMV 2020 (CLEAR) JIT | JOH | Substantially Equivalent | Passy-Muir, Inc. | accessdata.fda.gov |
| February 12, 1997 | K970365 | PASSY-MUIR O2 ADAPTER; PMA2000 | JOH | Substantially Equivalent | Passy-Muir, Inc. | accessdata.fda.gov |
| October 28, 1996 | K962714 | PASSY-MUIR LOW-PROFILE TRACHEOSTOMY AND VENTILATOR SPEAKING VALVE; PRODUCT NUMBER PMV 2000 OR PMTSV 2000 | JOH | Substantially Equivalent | Passy-Muir, Inc. | accessdata.fda.gov |
| July 7, 1995 | K944451 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVES (ONE-WAY TRACHEOSTOMY SPEAKING VALVES) | JOH | Substantially Equivalent | Passy-Muir, Inc. | accessdata.fda.gov |
| September 4, 1990 | K903699 | PASSY-MUIR TRACHEOSTOMY SPEAKING VALVE 15MM / 22MM | JOH | Substantially Equivalent | Passy & Passy, Inc. | accessdata.fda.gov |
| June 7, 1985 | K851016 | PASSY-MUIR TRACH VALVE | BTO | Substantially Equivalent | Passy & Passy, Inc. | accessdata.fda.gov |
Compare with other makers
- All makers of Connector, Airway (Extension)
- All makers of Tube Tracheostomy And Tube Cuff
- All makers of Tube, Tracheostomy (W/Wo Connector)
- All makers of Filter, Bacterial, Breathing-Circuit
- All makers of Condenser, Heat And Moisture (Artificial Nose)
Updated September 16, 2023. 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.