FDA product code JXE: Device, Nerve Conduction Velocity Measurement
JXE is the FDA product code for device, nerve conduction velocity measurement. It is a Class II device, regulated under 21 CFR 882.1550 and reviewed by the Neurology panel. FDA has cleared 27 510(k) submissions under JXE, 1 in the last five years, from 20 different applicants. The average 510(k) review took 157 days (median 99); 427 days on average over the last three years. FDA has posted 1 recall for JXE devices.
Classification
| Field | Value |
|---|---|
| Device name | Device, Nerve Conduction Velocity Measurement |
| Device class | Class II |
| Regulation | 21 CFR 882.1550 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
| Third-party 510(k) review eligible | Yes |
510(k) clearances per year for JXE
| Year | Clearances | Avg. review days |
|---|---|---|
| 2019 | 1 | 205 |
| 2025 | 1 | 427 |
Compare with all 510(k) review times · Search every JXE clearance
Top JXE applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Neurometrix, Inc. | 7 | 2008-04-25 |
| Chalgren Enterprises, Inc. | 2 | 1992-10-05 |
| Mde Orvosbiológiai Kutató, Fejleszto, | 1 | 2025-03-26 |
| Mediracer OY | 1 | 2019-09-25 |
| Excel Tech. , Ltd. | 1 | 2006-02-07 |
15 more applicants have JXE clearances. See the full list in Caduvo.
Most recent JXE clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K240189 | Mde Orvosbiológiai Kutató, Fejleszto, | NM-01/CPT neurometer (NM-01/CPT) | 2025-03-26 | 427 |
| K190536 | Mediracer OY | Mediracer NCS | 2019-09-25 | 205 |
| K070109 | Neurometrix, Inc. | NEUROMETRIX ADVANCE | 2008-04-25 | 470 |
| K060584 | Neurometrix, Inc. | NC-STAT | 2006-07-31 | 146 |
| K053058 | Excel Tech. , Ltd. | XLTEK NEUROPATH, MODEL PK1070 | 2006-02-07 | 99 |
Recalls for JXE devices
1 product recalls in 1 recall events; 0 initiated in the last five years and 0 still open. Most recent: 2012-04-18.
Frequently asked questions
What is FDA product code JXE?
JXE is the FDA product code for device, nerve conduction velocity measurement. It is a Class II device, regulated under 21 CFR 882.1550 and reviewed by the Neurology panel.
What device class is JXE?
Class II, regulation 21 CFR 882.1550. Typical premarket route: 510(k).
How long does a 510(k) take for product code JXE?
Across 27 cleared submissions the average was 157 days from receipt to decision (median 99).
Which companies have the most JXE clearances?
Neurometrix, Inc. (7); Chalgren Enterprises, Inc. (2); Mde Orvosbiológiai Kutató, Fejleszto, (1); Mediracer OY (1); Excel Tech. , Ltd. (1).
Have JXE devices been recalled?
Yes: 1 product recalls across 1 recall events; the most recent began 2012-04-18.
Next steps
- Run an FDA pathway report with predicate devices for product code JXE
- Run a recall and safety report across every JXE manufacturer
- Watch product code JXE 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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