510(k) · Cleared
ClearedProvox Vega, Model 8130-8135
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Atos Medical AB · EWL Prosthesis, Laryngeal (Taub)
Cleared on Jun 5, 2009 as substantially equivalent to K971244 (Atos Medical AB, 1997) after a 102-day review. Its family tree reaches back 1 generation to 1997. 2 later devices descend from it.
- Decided
- Jun 5, 2009
- Review
- 102 days
- Class
- Class II
- Product code
- EWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K971244 (1997). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK971244 Provox 2 Voice Prosthesis SystemAtos Medical AB · 1997
- This deviceK090455 Provox Vega, Model 8130-8135Atos Medical AB · 2009
- Descendant · cites it directly · 1 of its ownK131947 Provox Vega Puncture SetAtos Medical AB · 2013
- Descendant · 2 generations on · 0 of its ownK240763 FirstFit Surgical KitFreudenberg Medical, LLC · 2024
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K971244 | Provox 2 Voice Prosthesis System | Atos Medical AB | 1997 | — |
| 0 (this device) | K090455 | Provox Vega, Model 8130-8135 | Atos Medical AB | 2009 | — |
| +1 | K131947 | Provox Vega Puncture Set | Atos Medical AB | 2013 | — |
| +2 | K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in EWL? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new EWL device
- #1 K240763 FirstFit Surgical Kitscore 9.1 · 3 generations · no Class I recall
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K971244 | Provox 2 Voice Prosthesis SystemSummary page 1…/Code: EWL - Prosthesis, Laryngeal (Taub) Device: Provox® Vega TM Predicate Devices: Atos - Provox2 Voice Prosthesis - K971244 Device Description: The Provox Vega is a one-way valve (prosthesis) that keeps a TE-puncture open for speech, while reducing the… | 1997 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131947 | Provox Vega Puncture Set | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
How does its category compare?
All EWL devicesEWL Prosthesis, Laryngeal (Taub): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.
FDA decisions per year · EWL
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · EWL
Too few EWL 510(k)s in any year since 2007 to give a median.
Recalls per year · EWL
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · EWL
12in 2025
MAUDE reports naming product code EWL, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 21 |
| 2008 | 1 | — | 0 | 10 |
| 2009 | 1 | — | 0 | 6 |
| 2010 | 2 | — | 0 | 4 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 4 |
| 2013 | 1 | — | 1 | 5 |
| 2014 | 1 | — | 0 | 7 |
| 2015 | 0 | — | 0 | 11 |
| 2016 | 0 | — | 0 | 16 |
| 2017 | 0 | — | 0 | 15 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 7 |
| 2020 | 0 | — | 0 | 2 |
| 2021 | 0 | — | 0 | 7 |
| 2022 | 0 | — | 0 | 5 |
| 2023 | 0 | — | 0 | 4 |
| 2024 | 1 | — | 0 | 8 |
| 2025 | 0 | — | 0 | 12 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
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…
Read the full statement (131 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K090455 · printed Nov 3, 2026
Cite this page
510(k) Report. “K090455: Provox Vega, Model 8130-8135.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K090455
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026