510(k) · Cleared
ClearedProvox 2 Voice Prosthesis System
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 6, 1997 after a 64-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 6 later devices descend from it.
- Decided
- Jun 6, 1997
- Review
- 64 days
- Class
- Class II
- Product code
- EWL
- Recalls
- None
- Predicates
- 0
6 later devices descend from it, 3 citing it directly.
- This deviceK971244 Provox 2 Voice Prosthesis SystemAtos Medical AB · 1997
- Descendant · cites it directly · 2 of its ownK090455 Provox Vega, Model 8130-8135Atos Medical AB · 2009
- Descendant · 2 generations on · 1 of its ownK131947 Provox Vega Puncture SetAtos Medical AB · 2013
- Descendant · cites it directly · 1 of its ownK991587 Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999
- Descendant · 3 generations on · 0 of its ownK240763 FirstFit Surgical KitFreudenberg Medical, LLC · 2024
- Descendant · 2 generations on · 0 of its ownK082206 Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600…Helix Medical, LLC · 2008
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K090455Provox Vega, Model 8130-8135Atos Medical AB · 2009 · cites it directly2descendants
- K131947Provox Vega Puncture SetAtos Medical AB · 2013 · 2 generations on1descendant
- K991587Blom-Singer Indwelling 2000 Voice ProsthesisHelix Medical, Inc. · 1999 · cites it directly1descendant
- K240763FirstFit Surgical KitFreudenberg Medical, LLC · 2024 · 3 generations on0descendants
- K082206Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series, DV-2000 SeriesHelix Medical, LLC · 2008 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K971244 | Provox 2 Voice Prosthesis System | Atos Medical AB | 1997 | — |
| +1 | K090455 | Provox Vega, Model 8130-8135 | Atos Medical AB | 2009 | — |
| +2 | K131947 | Provox Vega Puncture Set | Atos Medical AB | 2013 | — |
| +1 | K991587 | Blom-Singer Indwelling 2000 Voice Prosthesis | Helix Medical, Inc. | 1999 | — |
| +3 | K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | 2024 | — |
| +2 | K082206 | Blom-Singer Dual Valve Indwelling Voice Prosthesis, Models DV-1600 Series… | Helix Medical, LLC | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2004 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2013 | 1 | 0 |
| 2024 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (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?
FDA’s file for it is a 510(k) statement, which names no predicate.
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K090455 (Atos Medical AB, 2009) has gone furthest, with 2 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.
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 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…
Read the full statement (132 words)
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.
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K971244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K971244: Provox 2 Voice Prosthesis System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K971244
Report an extraction error
Are you the manufacturer?
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