# K955634: Montgomery Tracheostomy Speaking Valve

- Pathway: 510(k) (Traditional)
- Applicant: Boston Medical Products, Inc.
- Decided: Jun 10, 1996 after 182 days
- Product code: CBP (Valve, Non-Rebreathing)
- Device class: 2
- Regulation: 21 CFR 868.5870
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Tracheostomy Speaking Valve (15mm / 22mm), Product No. 007: named in the summary without a submission number

## Indications for use
Montgomery® Tracheostomy Speaking Valves are designed to offer ventilator dependent patients the opportunity to speak without having to wait for the ventilator to cycle, allowing patients to speak during inspiration and expiration without interruption.

Source page: https://510kreport.com/device/K955634
Methodology: https://510kreport.com/methodology