# K072582: Provox Micron Hme

- Pathway: 510(k) (Traditional)
- Applicant: Atos Medical AB
- Decided: May 30, 2008 after 260 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: 6 generations back to K941381 (1994). 19 ancestors in all.
No later device cites it as a predicate yet.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K014102: Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251, Atos Medical AB (2002) Summary page 2.
- K022125: Provox Freehands Hme, Model 7710, Atos Medical AB (2002) Summary page 1.
- K915786: Blom-Singer Humid/Fil Syst Inhealth in-Line Humid., Helix Medical, Inc. (1992) Summary page 1.
- K043120: Min-Filter/S, Uni-Filter Junior, Uni-Filter/S Angled and Uni-Filter, Datex-Ohmeda, Inc. (2005) Summary page 1.

## Indications for use
The Provox® Micron HMETM is a specialized stoma cover that acts as a heat and moisture exchanger (HME) and air filtration device for laryngectomized patients. Provox® Micron HMETM partially restores lost breathing resistance due to laryngectomy. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing. It is intended to be used with the Provox®HME System. Environments of use include - hospitals, sub-acute care institutions and home.

Source page: https://510kreport.com/device/K072582
Methodology: https://510kreport.com/methodology