# K041485: Marpac Messenger Model #501

- Pathway: 510(k) (Traditional)
- Applicant: Marpac, Inc.
- Decided: Aug 2, 2004 after 59 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
Longest line of descent: 1 generation back to K903699 (1990). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K903699: Passy-Muir Tracheostomy Speaking Valve 15MM / 22MM, Passy & Passy, Inc. (1990) Summary page 1.

## Indications for use
The Marpac Messenger attaches to standard 15mm tracheostomy tubes and assists tracheostomy patients with speech by managing airflow.

Source page: https://510kreport.com/device/K041485
Methodology: https://510kreport.com/methodology