510(k) · Cleared
ClearedMochida Nerve Cuff
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mochida Pharmaceutical Co., Ltd. · JXI Cuff, Nerve
Cleared on Jun 21, 2024 as substantially equivalent to K060952 (Collagen Matrix, Inc., 2006) and 1 other predicate after a 266-day review. Its family tree reaches back 3 generations to 1985.
- Decided
- Jun 21, 2024
- Review
- 266 days
- Class
- Class II
- Product code
- JXI
- Recalls
- None
- Predicates
- 2
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 deviceK233322 Mochida Nerve CuffMochida Pharmaceutical Co., Ltd. · 2024
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) | K233322 | Mochida Nerve Cuff | Mochida Pharmaceutical Co., Ltd. | 2024 | — |
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? (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 |
|---|---|---|---|
| * | K060952 | Collagen Nerve WrapSummary page 5…ification name: Nerve cuff (21 CFR 882.5275) Regulatory class: II Product code: JXI Predicate Devices Collagen Matrix, Inc.’s Collagen Nerve Wrap (K060952) (Predicate device) Collagen Matrix, Inc.’s Collagen Nerve Cuff (K012814) (Predicate device) Device Description T… | 2006 |
| * | K012814 | Collagen Nerve CuffSummary page 5…Product code: JXI Predicate Devices Collagen Matrix, Inc.’s Collagen Nerve Wrap (K060952) (Predicate device) Collagen Matrix, Inc.’s Collagen Nerve Cuff (K012814) (Predicate device) Device Description The Mochida Nerve Cuff is made from a polyglycolic acid (PGA) sheet embedded into… | 2001 |
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 39 years and passes through 3 companies; a new generation was cleared every 16.2 years on median.
- 2 of the 6 ancestors have a recall of any class.
- 3 other devices also cite its predicate K060952.
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?
Mochida Nerve Cuff is indicated for the repair of peripheral nerve discontinuities where gap closure can be achieved by flexion of the extremity, or 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/K233322 · printed Nov 4, 2026
Cite this page
510(k) Report. “K233322: Mochida Nerve Cuff.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K233322
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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