# K022125: Provox Freehands Hme, Model 7710

- Pathway: 510(k) (Special)
- Applicant: Atos Medical AB
- Decided: Jul 30, 2002 after 29 days
- Product code: EWL (Prosthesis, Laryngeal (Taub))
- Device class: 2
- Regulation: 21 CFR 874.3730
- 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 K821568 (1982). 3 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 6 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)
- K821568: Blow-Singer Tracheostoma Valve, Bivona Medical Technologies (1982) Summary page 1.
- K852272: Bivona Tracheostoma Valve II, Bivona Medical Technologies (1985) Summary page 1.

## Most influential descendants
- K141380: Provox Freehands Flexivoice (2014), 0 descendants of its own
- K072582: Provox Micron Hme (2008), 0 descendants of its own

## Indications for use
The Provox FreeHands system is a heat and moisture exchanger (HME) that heats and humidifies inhaled air by retaining heat and moist from exhaled air in the device. For patients with a voice prosthesis or surgical speech fistula it may also facilitate voicing.

Source page: https://510kreport.com/device/K022125
Methodology: https://510kreport.com/methodology