510(k) · Cleared
ClearedFirstFit Surgical Kit
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Freudenberg Medical, LLC · EWL Prosthesis, Laryngeal (Taub)
Cleared on Dec 18, 2024 as substantially equivalent to K131947 (Atos Medical AB, 2013) after a 273-day review. Its family tree reaches back 3 generations to 1997.
- Decided
- Dec 18, 2024
- Review
- 273 days
- Class
- Class II
- Product code
- EWL
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K971244 (1997). 4 ancestors in all, the oldest K940638 (1994). No later device cites it as a predicate yet.
- Root · 3 generations backK971244 Provox 2 Voice Prosthesis SystemAtos Medical AB · 1997
- 2 generations backK090455 Provox Vega, Model 8130-8135Atos Medical AB · 2009
- 1 generation backK131947 Provox Vega Puncture SetAtos Medical AB · 2013
- This deviceK240763 FirstFit Surgical KitFreudenberg Medical, LLC · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K971244 | Provox 2 Voice Prosthesis System | Atos Medical AB | 1997 | — |
| −2 | K090455 | Provox Vega, Model 8130-8135 | Atos Medical AB | 2009 | — |
| −1 | K131947 | Provox Vega Puncture Set | Atos Medical AB | 2013 | — |
| 0 (this device) | K240763 | FirstFit Surgical Kit | Freudenberg Medical, LLC | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
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 |
|---|---|---|---|
| * | K131947 | Provox Vega Puncture SetSummary page 5…n Name: Prosthesis, Laryngeal (Taub) Regulation: 21 CFR 874.3730 Regulatory Class: II Primary Product Code: EWL PREDICATE DEVICES Predicate: Provox® Vega Puncture Set, (K131947) DEVICE DESCRIPTION The FirstFit Surgical Kit (FFSK) is a kit for creating a primary or secondary TE puncture, with subsequent d… | 2013 |
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?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 11.2 years on median.
- None of the 4 ancestors has a recall.
How does its category compare?
All EWL devicesEWL Prosthesis, Laryngeal (Taub): FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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 Blom-Singer® FirstFit™ Surgical Kit (FFSK) is indicated for use during surgical creation of primary or secondary tracheoesophageal puncture, dilation of the tracheoesophageal wall, and to guide the placement of the voice prosthesis for tracheoesophageal voice restoration following total laryngectomy.
The FFSK contains a sterile single use indwelling Blom-Singer® Indwelling Voice Prosthesis device 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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K240763 · printed Nov 5, 2026
Cite this page
510(k) Report. “K240763: FirstFit Surgical Kit.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K240763
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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