# K962714: Passy-Muir Low-Profile Tracheostomy and Ventilator Speaking Valve; Product Number PMV 2000 or Pmtsv 2000

- Pathway: 510(k) (Traditional)
- Applicant: Passy-Muir, Inc.
- Decided: Oct 28, 1996 after 108 days
- Product code: JOH (Tube Tracheostomy And Tube Cuff)
- Device class: 2
- Regulation: 21 CFR 868.5800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
1 later device descends from it; 1 cites it directly.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K062104: Talking Trach (2007), 0 descendants of its own

Source page: https://510kreport.com/device/K962714
Methodology: https://510kreport.com/methodology