FDA product code JXI: Cuff, Nerve
JXI is the FDA product code for cuff, nerve. It is a Class II device, regulated under 21 CFR 882.5275 and reviewed by the Neurology panel. FDA has cleared 40 510(k) submissions under JXI, 14 in the last five years, from 25 different applicants. The average 510(k) review took 167 days (median 116); 149 days on average over the last three years. FDA has posted 4 recalls for JXI devices, 1 initiated in the last five years.
Classification
| Field | Value |
|---|---|
| Device name | Cuff, Nerve |
| Device class | Class II |
| Regulation | 21 CFR 882.5275 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Implant | Yes |
510(k) clearances per year for JXI
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 3 | 120 |
| 2018 | 1 | 89 |
| 2019 | 1 | 114 |
| 2020 | 1 | 90 |
| 2022 | 2 | 524 |
| 2023 | 3 | 121 |
| 2024 | 3 | 227 |
| 2025 | 4 | 130 |
| 2026 | 2 | 90 |
Compare with all 510(k) review times · Search every JXI clearance
Top JXI applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Collagen Matrix, Inc. | 4 | 2017-06-01 |
| Axogen Corporation | 3 | 2023-10-12 |
| Polyganics B.V., | 3 | 2011-10-20 |
| Alafair Biosciences | 2 | 2025-07-22 |
| Biocircuit Technologies, Inc. | 2 | 2025-04-02 |
20 more applicants have JXI clearances. See the full list in Caduvo.
Most recent JXI clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260245 | KLISBio S.r.l. | SILKBridge | 2026-04-09 | 72 |
| K253363 | Auxilium Biotechnologies, Inc. | NeuroSpan Bridge | 2026-01-17 | 109 |
| K251505 | Alafair Biosciences | VersaCoat Nerve Protector (VTP-44G2); VersaCoat Nerve Protector (VTP-12G1) | 2025-07-22 | 67 |
| K251175 | Alafair Biosciences | VersaWrap Nerve Protector (VTP-2201); VersaWrap Nerve Protector (VTP-1201) | 2025-07-17 | 92 |
| K242113 | Biocircuit Technologies, Inc. | Nerve Wrap (07-DW-001-TAB) | 2025-04-02 | 257 |
Recalls for JXI devices
4 product recalls in 3 recall events; 1 initiated in the last five years and 1 still open. Most recent: 2023-03-27.
| Year | Recalls |
|---|---|
| 2020 | 1 |
| 2023 | 1 |
Frequently asked questions
What is FDA product code JXI?
JXI is the FDA product code for cuff, nerve. It is a Class II device, regulated under 21 CFR 882.5275 and reviewed by the Neurology panel.
What device class is JXI?
Class II, regulation 21 CFR 882.5275. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXI?
Across 40 cleared submissions the average was 167 days from receipt to decision (median 116).
Which companies have the most JXI clearances?
Collagen Matrix, Inc. (4); Axogen Corporation (3); Polyganics B.V., (3); Alafair Biosciences (2); Biocircuit Technologies, Inc. (2).
Have JXI devices been recalled?
Yes: 4 product recalls across 3 recall events; the most recent began 2023-03-27.
Next steps
- Run an FDA pathway report with predicate devices for product code JXI
- Run a recall and safety report across every JXI manufacturer
- Watch product code JXI for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
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