510(k) · Cleared
ClearedProvox Vega Puncture Set
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 Oct 18, 2013 as substantially equivalent to K090455 (Atos Medical AB, 2009) and 1 other predicate after a 113-day review. Its family tree reaches back 2 generations to 1997. 1 later device descends from it.
- Decided
- Oct 18, 2013
- Review
- 113 days
- Class
- Class II
- Product code
- EWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K971244 (1997). 3 ancestors in all, the oldest K940638 (1994). 1 later device descends from it, 1 citing it directly.
- Root · 2 generations backK971244 Provox 2 Voice Prosthesis SystemAtos Medical AB · 1997
- 1 generation backK090455 Provox Vega, Model 8130-8135Atos Medical AB · 2009
- This deviceK131947 Provox Vega Puncture SetAtos Medical AB · 2013
- Descendant · cites it directly · 0 of its ownK240763 FirstFit Surgical KitFreudenberg Medical, LLC · 2024
Most influential descendants
Showing 1 of 1 · See all- K240763FirstFit Surgical KitFreudenberg Medical, LLC · 2024 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K971244 | Provox 2 Voice Prosthesis System | Atos Medical AB | 1997 | — |
| −1 | K090455 | Provox Vega, Model 8130-8135 | Atos Medical AB | 2009 | — |
| 0 (this device) | K131947 | Provox Vega Puncture Set | Atos Medical AB | 2013 | — |
| +1 | K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K090455 | Provox Vega, Model 8130-8135Summary page 1…vox® VegaTM Puncture Set Predicate Devices: Atos Medical - Provoxi® VegaTm Voice Prosthesis with Smartlnserter - (K090455) Atos Medical - Provox Voice Prosthesis - (K940638) Device Description: The Provox Vega Pu… | 2009 |
| * | K940638 | Provox (TM) Voice ProsthesisSummary page 1…egaTm Voice Prosthesis with Smartlnserter - (K090455) Atos Medical - Provox Voice Prosthesis - (K940638) Device Description: The Provox Vega Puncture Set is a device for creating a primary or secondary TE puncture, with subsequent… | 1994 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K240763 | FirstFit Surgical Kit | 2024 | 0 |
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?
- The line of descent spans 16 years and passes through 1 company; a new generation was cleared every 12.0 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K240763 (Freudenberg Medical, LLC, 2024) has gone furthest, with 0 descendants of its own.
How does its category compare?
All EWL devicesEWL Prosthesis, Laryngeal (Taub): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, 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?
Provox® VegaTM Puncture Set is a device for performing a primary or secondary tracheo-esophageal (TE) puncture in laryngectomized patients, with integrated placement of a Provox Vega voice prosthesis.
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 performed by the patient while it remains in situ.
Environments of use include;
- Provox Vega Puncture Set - Hospitals
- Provox Vega Voice Prosthesis - Hospitals, sub-acute care institutions and home.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K131947 · printed Nov 6, 2026
Cite this page
510(k) Report. “K131947: Provox Vega Puncture Set.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K131947
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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