510(k) · Cleared
ClearedProvox Nid Voice Rehabilitation System, Model Ref 7101 to 7134
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 Nov 22, 2004 as substantially equivalent to K971244 (Atos Medical AB, 1997) and 1 other predicate after a 10-day review. Its family tree reaches back 1 generation to 1982.
- Decided
- Nov 22, 2004
- Review
- 10 days
- Class
- Class II
- Product code
- EWL
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 1 generation to K821568 (1982). 2 ancestors in all. No later device cites it as a predicate yet.
- Root · 1 generation backK821568 Blow-Singer Tracheostoma ValveBivona Medical Technologies · 1982 · Recalled
- This deviceK043138 Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134Atos Medical AB · 2004
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K821568 | Blow-Singer Tracheostoma Valve | Bivona Medical Technologies | 1982 | 1 |
| 0 (this device) | K043138 | Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134 | Atos Medical AB | 2004 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 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 |
|---|---|---|---|
| * | K971244 | Provox 2 Voice Prosthesis SystemSummary page 2…Page 2 of 3 Predicate Provox®2 Voice Prosthesis System Devices 5 10(k) Number: K971244 Atos Medical AB, Sweden Blom-Singer Low Pressure Voice Prosthesis 5 10O… | 1997 |
| * | K821568 | Blow-Singer Tracheostoma ValveSummary page 2…(k) Number: K971244 Atos Medical AB, Sweden Blom-Singer Low Pressure Voice Prosthesis 5 10O(k) Number: K821568 Inhealth Technologies, USA Intended Use The Provox NID voice rehabilitation system is intended for use… | 1982 |
What descends from it?
No later submission names this one as a predicate yet.
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?
- 1 of the 2 ancestors has a recall of any class.
- 2 other devices also cite its predicate K971244.
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® NIDTM Voice Rehabilitation System is intended for use in prosthetic voice rehabilitation after total laryngectomy only by patients who have been trained in the use of the device and, as assessed by the clinician who prescribes the device, have demonstrated the ability to understand and consistently follow the Instructions for Use without clinician supervision.
The Provox NID is intended for single patient use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K043138 · printed Nov 6, 2026
Cite this page
510(k) Report. “K043138: Provox Nid Voice Rehabilitation System, Model Ref 7101 to 7134.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K043138
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