# Passy & Passy, Inc.

- Location (FDA's records): Irvine, CA
- FDA decisions: 2 (1985–1990): 2 510(k) clearances
- Product codes: JOH (1), BTO (1)
- Predicates its devices cite: 0 (0 its own); citations of its devices by later devices: 1 (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 that cite its devices most
- Marpac, Inc.: 1 (https://510kreport.com/company/marpac)

## Its most-cited devices
- K903699: Passy-Muir Tracheostomy Speaking Valve 15MM / 22MM (1990), cited by 1

## Recent decisions
- K903699: Passy-Muir Tracheostomy Speaking Valve 15MM / 22MM (Sep 4, 1990)
- K851016: Passy-Muir Trach Valve (Jun 7, 1985)

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