# Passy-Muir, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 5 (1995–2023): 5 510(k) clearances
- Product codes: JOH (4), CAH (1)
- Predicates its devices cite: 1 (0 its own); citations of its devices by later devices: 3 (0 its own)
- Recalls linked to its devices: 0 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Meditera Tibbi Malzeme San VE Tic AS: 1 (https://510kreport.com/company/meditera-tibbi-malzeme-san-ve-tic)

## Firms that cite its devices most
- Engineered Medical Systems: 2 (https://510kreport.com/company/engineered-medical-systems)
- Pilling Weck Surgical: 1 (https://510kreport.com/company/pilling-weck-surgical)

## Its most-cited devices
- K944451: Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves) (1995), cited by 2
- K962714: Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valve; Product Number PMV 2000 or Pmtsv 2000 (1996), cited by 1

## Recent decisions
- K230483: Passy Muir Tracheostomy Viral & Bacterial Airway Protection Filter (PM-APF15) (Sep 16, 2023)
- K990905: Passy-Muir Low-Profile Tracheostomy Speaking Valve PMV 2020 (Clear) Jit (Jun 11, 1999)
- K970365: Passy-Muir O2 Adapter; PMA2000 (Feb 12, 1997)
- K962714: Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valve; Product Number PMV 2000 or Pmtsv 2000 (Oct 28, 1996)
- K944451: Passy-Muir Tracheostomy Speaking Valves (One-Way Tracheostomy Speaking Valves) (Jul 7, 1995)

Source page: https://510kreport.com/company/passy-muir