# K971244: Provox 2 Voice Prosthesis System

- Pathway: 510(k) (Traditional)
- Applicant: Atos Medical AB
- Decided: Jun 6, 1997 after 64 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
No predicates in its family tree.
6 later devices descend from it; 3 cite it directly.
0 of 7 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
- K090455: Provox Vega, Model 8130-8135 (2009), 2 descendants of its own
- K131947: Provox Vega Puncture Set (2013), 1 descendant of its own
- K991587: Blom-Singer Indwelling 2000 Voice Prosthesis (1999), 1 descendant of its own
- K240763: FirstFit Surgical Kit (2024), 0 descendants of its own
- K082206: Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 Series (2008), 0 descendants of its own

## Indications for use
The PROVOX Voice Rehabilitation System has exactly the same indications for use as the original PROVOX and is intended for use in prosthetic voice restoration after total laryngectomy. The prosthesis can be inserted at the time of laryngectomy (primary puncture), or at a later date (secondary puncture), or to replace another similar prosthesis. Replacement is performed in an anterograde way, using the components accompanying the PROVOX2 device (Insertion tool). The development of an anterograde replacement method (through the tracheostoma) was a logical development since the retrograde replacement method (using a guide wire) is often discomfortable for the patient. The PROVOX2 can be used in primary or secondary TE-puncture procedures if it is used with the PROVOX GuideWire, the Trocar and Cannula, and the Pharynx Protector components of the PROVOX Voice Rehabilitation System.

Source page: https://510kreport.com/device/K971244
Methodology: https://510kreport.com/methodology