510(k) · Cleared
ClearedNerveTape
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Biocircuit Technologies, Inc. · JXI Cuff, Nerve
Cleared on Feb 12, 2024 as substantially equivalent to K210665 (Biocircuit Technologies, Incorporated, 2022) after a 102-day review. Its family tree reaches back 6 generations to 1992.
- Decided
- Feb 12, 2024
- Review
- 102 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K921895 (1992). 14 ancestors in all, the oldest K830889 (1983). No later device cites it as a predicate yet.
- Root · 6 generations backK921895 Tissue Patch, Tissue GraftBio-Vascular, Inc. · 1992
- 5 generations backK961810 Supple Peri-Guard PericardiumBio-Vascular, Inc. · 1996
- 4 generations backK980431 SurgisisCook Biotech, Inc. · 1998
- 3 generations backK031069 Surgisis Nerve CuffCook Biotech, Inc. · 2003
- 2 generations backK132660 Nerve CuffCook Biotech Incorporated · 2014
- 1 generation backK210665 Nerve TapeBiocircuit Technologies, Incorporated · 2022
- This deviceK233533 NerveTapeBiocircuit Technologies, Inc. · 2024
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K921895 | Tissue Patch, Tissue Graft | Bio-Vascular, Inc. | 1992 | — |
| −5 | K961810 | Supple Peri-Guard Pericardium | Bio-Vascular, Inc. | 1996 | — |
| −4 | K980431 | Surgisis | Cook Biotech, Inc. | 1998 | — |
| −3 | K031069 | Surgisis Nerve Cuff | Cook Biotech, Inc. | 2003 | — |
| −2 | K132660 | Nerve Cuff | Cook Biotech Incorporated | 2014 | — |
| −1 | K210665 | Nerve Tape | Biocircuit Technologies, Incorporated | 2022 | — |
| 0 (this device) | K233533 | NerveTape | Biocircuit Technologies, Inc. | 2024 | — |
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 |
| 2016 | 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 |
|---|---|---|---|
| * | K210665 | Nerve TapeSummary page 5…21 CFR §882.5275 (JXI) Class II E. Predicate Device: PRIMARY: BioCircuit Technologies, Inc. Nerve Tape™ (K210665) REFERENCE: AxoGuard® Nerve Connector (K162741) F. Physical Description: The proposed BioCircuit Techn… | 2022 |
| † | K162741 | AxoGuard Nerve Connector | 2016 |
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 32 years and passes through 5 companies; a new generation was cleared every 5.0 years on median.
- 1 of the 14 ancestors has a recall of any class.
How does its category compare?
All JXI devicesJXI Cuff, Nerve: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, 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?
NerveTape is indicated for the 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/K233533 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233533: NerveTape.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233533
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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