510(k) · Cleared
ClearedSalumedica Nerve Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Salumedica, LLC · JXI Cuff, Nerve
Cleared on Nov 24, 2000 after a 136-day review. The FDA summary names its predicate without a number. 40 later devices descend from it.
- Decided
- Nov 24, 2000
- Review
- 136 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 0
40 later devices descend from it, 5 citing it directly.
- This deviceK002098 Salumedica Nerve CuffSalumedica, LLC · 2000
- Descendant · cites it directly · 37 of its ownK012814 Collagen Nerve CuffCollagen Matrix, Inc. · 2001
- Descendant · 2 generations on · 22 of its ownK060952 Collagen Nerve WrapCollagen Matrix, Inc. · 2006
- Descendant · 3 generations on · 15 of its ownK080452 Collagen Tendon WrapCollagen Matrix, Inc. · 2008
- Descendant · 4 generations on · 14 of its ownK112423 Collagen Tendon SheetRotation Medical, Inc. · 2011
- Descendant · cites it directly · 10 of its ownK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
Showing 5 of 40 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 40 · See all- K012814Collagen Nerve CuffCollagen Matrix, Inc. · 2001 · cites it directly37descendants
- K060952Collagen Nerve WrapCollagen Matrix, Inc. · 2006 · 2 generations on22descendants
- K080452Collagen Tendon WrapCollagen Matrix, Inc. · 2008 · 3 generations on15descendants
- K112423Collagen Tendon SheetRotation Medical, Inc. · 2011 · 4 generations on14descendants
- K031069Surgisis Nerve CuffCook Biotech, Inc. · 2003 · cites it directly10descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002098 | Salumedica Nerve Cuff | Salumedica, LLC | 2000 | — |
| +1 | K012814 | Collagen Nerve Cuff | Collagen Matrix, Inc. | 2001 | — |
| +2 | K060952 | Collagen Nerve Wrap | Collagen Matrix, Inc. | 2006 | — |
| +3 | K080452 | Collagen Tendon Wrap | Collagen Matrix, Inc. | 2008 | — |
| +4 | K112423 | Collagen Tendon Sheet | Rotation Medical, Inc. | 2011 | — |
| +1 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2001 | 1 | 0 |
| 2003 | 1 | 0 |
| 2005 | 1 | 0 |
| 2006 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 4 | 0 |
| 2016 | 3 | 0 |
| 2017 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 3 | 0 |
| 2023 | 5 | 0 |
| 2024 | 5 | 0 |
| 2025 | 5 | 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? (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 |
|---|---|---|---|
| * | — | FastubeTM Nerve Cuff Named without a submission number | |
| * | — | silicone nerve cuffs Named without a submission number |
What descends from it? (40)
See all 405 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, K012814 (Collagen Matrix, Inc., 2001) has gone furthest, with 37 descendants of its own.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years.
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?
Repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K002098 · printed Nov 6, 2026
Cite this page
510(k) Report. “K002098: Salumedica Nerve Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K002098
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026