510(k) · Cleared
ClearedVersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Alafair Biosciences · JXI Cuff, Nerve
Cleared on Jul 22, 2025 as substantially equivalent to K232029 (Alafair Biosciences, Inc., 2023) after a 67-day review. Its family tree reaches back 3 generations to 2004.
- Decided
- Jul 22, 2025
- Review
- 67 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K041620 (2004). No later device cites it as a predicate yet.
- Root · 3 generations backK041620 Neura Wrap Nerve ProtectorIntegra Lifesciences Corp. · 2004 · Recalled
- 2 generations backK201631 VersaWrap Nerve ProtectorAlafair Biosciences, Inc. · 2020
- 1 generation backK232029 VersaWrap Nerve ProtectorAlafair Biosciences, Inc. · 2023
- This deviceK251505 VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector…Alafair Biosciences · 2025
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K041620 | Neura Wrap Nerve Protector | Integra Lifesciences Corp. | 2004 | 1 |
| −2 | K201631 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2020 | — |
| −1 | K232029 | VersaWrap Nerve Protector | Alafair Biosciences, Inc. | 2023 | — |
| 0 (this device) | K251505 | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | Alafair Biosciences | 2025 | — |
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 JXI? 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 JXI device
- #1 K232029 VersaWrap Nerve Protectorscore 12.6 · 2 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K232029 | VersaWrap Nerve ProtectorSummary page 5…or Common Name Cuff, Nerve Classification number 21 CFR 882.5275 Product Code JXI Legally Marketed Predicate Device VersaWrap Nerve Protector (K232029) Device Description Summary VersaCoat Nerve Protector is an absorbable implant (device) designed to function as a gelatinous inte… | 2023 |
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 21 years and passes through 3 companies; a new generation was cleared every 3.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 1 other device also cites its predicate K232029.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, this device’s year, is highlighted.
FDA decisions per year · JXI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JXI
99in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JXI
No recall names JXI since 2007.
Adverse event reports per year · JXI
18in 2025
MAUDE reports naming product code JXI, 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 | 0 |
| 2008 | 0 | — | 0 | 7 |
| 2009 | 0 | — | 0 | 7 |
| 2010 | 1 | — | 0 | 8 |
| 2011 | 1 | — | 0 | 11 |
| 2012 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 7 |
| 2014 | 3 | 309 | 0 | 7 |
| 2015 | 1 | — | 0 | 5 |
| 2016 | 3 | 117 | 0 | 8 |
| 2017 | 3 | 90 | 0 | 9 |
| 2018 | 1 | — | 0 | 6 |
| 2019 | 1 | — | 0 | 10 |
| 2020 | 1 | — | 0 | 5 |
| 2021 | 0 | — | 0 | 3 |
| 2022 | 2 | — | 0 | 8 |
| 2023 | 3 | 122 | 0 | 15 |
| 2024 | 3 | 266 | 0 | 18 |
| 2025 | 4 | 99 | 0 | 18 |
| 2026 | 2 | — | 0 | — |
What is it indicated for?
VersaCoat Nerve Protector is indicated for the management of peripheral nerve injuries in which there has been no substantial loss of nerve tissue.
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/K251505 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251505: VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251505
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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