# K090455: Provox Vega, Model 8130-8135

- Pathway: 510(k) (Traditional)
- Applicant: Atos Medical AB
- Decided: Jun 5, 2009 after 102 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 K971244 (1997). 1 ancestor in all.
2 later devices descend from it; 1 cites 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)
- K971244: Provox 2 Voice Prosthesis System, Atos Medical AB (1997) Summary page 1.

## Most influential descendants
- K131947: Provox Vega Puncture Set (2013), 1 descendant of its own
- K240763: FirstFit Surgical Kit (2024), 0 descendants of its own

## Indications for use
The Provox® Vega Voice Prosthesis is a sterile single use indwelling voice prosthesis intended for voice rehabilitation after surgical removal of the larynx (laryngectomy). Cleaning of the voice prosthesis is handled by the Patient while it remains in situ. The Provox SmartInserter is a sterile single use device intended for anterograde replacement of the Provox Vega Voice Prosthesis. This replacement procedure is carried out by a medical doctor or a trained medical professional in accordance with local or national guidelines. The Provox SmartInserter is not intended to be used for insertion of a voice prosthesis in a freshly made puncture. Environments of use for the Provox® Vega Voice Prosthesis include - hospitals, sub-acute care institutions and home. For the Provox SmartInserter environments of use include - hospitals and sub-acute care institutions.

Source page: https://510kreport.com/device/K090455
Methodology: https://510kreport.com/methodology