# K014102: Provox Hme Cassette, Model 7240; Provox Adhesive, Model 7251

- Pathway: 510(k) (Special)
- Applicant: Atos Medical AB
- Decided: Feb 21, 2002 after 70 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.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K022125: Provox Freehands Hme, Model 7710 (2002), 2 descendants of its own
- 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 HME 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/K014102
Methodology: https://510kreport.com/methodology