510(k) · Cleared
ClearedSalutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salumedica, LLC · JXI Cuff, Nerve
Cleared on Aug 5, 2010 as substantially equivalent to K002098 (Salumedica, LLC, 2000) and 2 other predicates after a 170-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Aug 5, 2010
- Review
- 170 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K850785 (1985). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK850785 Fastube Nerve Regeneration DeviceResearch Medical, Inc. · 1985
- 2 generations backK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- 1 generation backK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- This deviceK100382 Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331Salumedica, LLC · 2010
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K850785 | Fastube Nerve Regeneration Device | Research Medical, Inc. | 1985 | — |
| −2 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| −1 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| 0 (this device) | K100382 | Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331 | Salumedica, LLC | 2010 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2000 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 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 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? (3)
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 |
|---|---|---|---|
| * | K002098 | Salumedica Nerve CuffSummary page 1…use to the following products which have been cleared to market under Premarket Notifications 5 10O(k): SaluBridge Nerve Cuff (fka SaluMedica Nerve Cuff, K002098), Integra Lifesciences Corporation NeuroWrapTm Nerve Protector (K04 1620), and Collagen Matrix, Inc., NeuroMendTm Collagen… | 2000 |
| * | K041620 | Neura Wrap Nerve ProtectorSummary page 1…arket Notifications 5 10O(k): SaluBridge Nerve Cuff (fka SaluMedica Nerve Cuff, K002098), Integra Lifesciences Corporation NeuroWrapTm Nerve Protector (K04 1620), and Collagen Matrix, Inc., NeuroMendTm Collagen Nerve Wrap (K(060952). The basis for equivalence is demonstrated by the c… | 2004 |
| * | K060952 | Collagen Nerve WrapSummary page 1…Cuff, K002098), Integra Lifesciences Corporation NeuroWrapTm Nerve Protector (K04 1620), and Collagen Matrix, Inc., NeuroMendTm Collagen Nerve Wrap (K(060952). The basis for equivalence is demonstrated by the comparisons in the following table:… | 2006 |
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 25 years and passes through 3 companies; a new generation was cleared every 4.8 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 4 other devices also cite its predicate K002098.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2010, 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?
The SaluTunnel™ 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 as stated in the FDA summary.
https://510kreport.com/device/K100382 · printed Nov 6, 2026
Cite this page
510(k) Report. “K100382: Salutunnel Nerve Protector, Model ED-20329, ED-20330, ED-20331.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K100382
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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