510(k) · Cleared
ClearedNerve Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Cook Biotech Incorporated · JXI Cuff, Nerve
Cleared on Jan 10, 2014 as substantially equivalent to K031069 (Cook Biotech, Inc., 2003) after a 137-day review. Its family tree reaches back 4 generations to 1992. 6 later devices descend from it.
- Decided
- Jan 10, 2014
- Review
- 137 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K921895 (1992). 11 ancestors in all, the oldest K830889 (1983). 6 later devices descend from it, 3 citing it directly.
- Root · 4 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 3 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 2 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 1 generation backK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
- This deviceK132660 Nerve CuffCook Biotech Incorporated · 2014
- Descendant · cites it directly · 2 of its ownK223640 Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector…Axogen Corporation · 2023
- Descendant · cites it directly · 1 of its ownK210665 Nerve TapeBiocircuit Technologies, Incorporated · 2022
- Descendant · 2 generations on · 0 of its ownK242113 Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK233533 NerveTapeBiocircuit Technologies, Inc. · 2024
- Descendant · 2 generations on · 0 of its ownK231708 Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector…Axogen Corporation · 2023
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K223640Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation · 2023 · cites it directly2descendants
- K210665Nerve TapeBiocircuit Technologies, Incorporated · 2022 · cites it directly1descendant
- K242113Nerve Wrap (07-DW-001-TAB)Biocircuit Technologies, Inc. · 2025 · 2 generations on0descendants
- K233533NerveTapeBiocircuit Technologies, Inc. · 2024 · 2 generations on0descendants
- K231708Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22); Axoguard…Axogen Corporation · 2023 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −3 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −2 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −1 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
| 0 (this device) | K132660 | Nerve Cuff | Cook Biotech Incorporated | 2014 | — |
| +1 | K223640 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22)… | Axogen Corporation | 2023 | — |
| +1 | K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | 2022 | — |
| +2 | K242113 | Nerve Wrap (07-DW-001-TAB) | Biocircuit Technologies, Inc. | 2025 | — |
| +2 | K233533 | NerveTape | Biocircuit Technologies, Inc. | 2024 | — |
| +2 | K231708 | Axoguard HA+ Nerve Protector (AGHA12); Axoguard HA+ Nerve Protector (AGHA22)… | Axogen Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1983 | 1 | 0 |
| 1985 | 1 | 0 |
| 1992 | 1 | 0 |
| 1997 | 1 | 0 |
| 2000 | 1 | 0 |
| 2001 | 2 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2022 | 2 | 0 |
| 2023 | 2 | 0 |
| 2024 | 1 | 0 |
| 2025 | 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? (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 |
|---|---|---|---|
| * | K031069 | Surgisis Nerve CuffSummary page 1…rbable, extracellular collagen matrix (Small Intestinal Submucosa, SIS). The SIS material that comprises the Nerve Cuff is identical to that of its predicate Nerve Cuff (K03 1069), also manufactured by Cook Biotech Incorporated. The Nerve Cuff is implanted providing a scaffold which becomes infiltrated by t… | 2003 |
What descends from it? (6)
3 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?
- The line of descent spans 22 years and passes through 3 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 11 ancestors has a recall of any class.
- Of its descendants, K223640 (Axogen Corporation, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K031069.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, 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 Nerve, Cuff is indicated for the repair of peripheral nerve injuries in which there is no gap or where a gap closure is achieved by flexion of the extremity. The device is provided sterile and intended for one-time use.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K132660 · printed Nov 6, 2026
Cite this page
510(k) Report. “K132660: 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/K132660
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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