Neurometrix, Inc.: FDA filings under this applicant name
FDA lists 17 510(k) clearances under the applicant name “Neurometrix, Inc.” (first 1998, latest 2016), plus 1 De Novo decision, across 7 product codes in 2 review panels. Median 510(k) review time under this name: 106 days. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 2 | 132 |
| 2013 | 1 | 90 |
| 2014 | 2 | 199 |
| 2015 | 0 | — |
| 2016 | 1 | 90 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| JXE | Device, Nerve Conduction Velocity Measurement | 7 | 7 |
| GXY | Electrode, Cutaneous | 4 | 4 |
| GZJ | Stimulator, Nerve, Transcutaneous, For Pain Relief | 2 | 2 |
| NUH | Stimulator, Nerve, Transcutaneous, Over-The-Counter | 2 | 2 |
| BXN | Stimulator, Nerve, Battery-Powered | 1 | 1 |
| GWL | Amplifier, Physiological Signal | 1 | 1 |
| QSQ | Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms | 1 | 0 |
Review panels
- Neurology (17)
- Anesthesiology (1)
Most recent Neurometrix, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K152954 | Quell | NUH | 2016-01-05 | 90 |
| K140586 | ASCEND ELECTRODE | GXY | 2014-11-17 | 255 |
| K140333 | ASCEND | NUH | 2014-07-03 | 143 |
| K130919 | SENSUS | GZJ | 2013-07-02 | 90 |
| K121816 | SENSUS ELECTRODE | GXY | 2012-11-26 | 159 |
| K121184 | SENSUS | GZJ | 2012-08-02 | 106 |
| K091155 | ASCEND | BXN | 2009-09-03 | 135 |
| K083322 | NEUROMETRIX BIOAMPLIFIER | GWL | 2009-05-27 | 196 |
| K083818 | UNIVERSAL ELECTRODES | GXY | 2009-01-21 | 30 |
| K081871 | UNIVERSAL ELECTRODES | GXY | 2008-09-29 | 90 |
7 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN210046 | De Novo | Transcutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms | 2022-05-18 |
Recalls
openFDA lists no recalls under a recalling firm named Neurometrix, Inc..
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neurometrix, Inc.?
FDA lists 17 510(k) clearances under the applicant name “Neurometrix, Inc.” (first 1998, latest 2016), plus 1 De Novo decision, across 7 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neurometrix, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neurometrix, Inc. is 106 days.
Which FDA product codes appear under Neurometrix, Inc.?
The most frequent FDA product codes under this applicant name are JXE (Device, Nerve Conduction Velocity Measurement, 7); GXY (Electrode, Cutaneous, 4); GZJ (Stimulator, Nerve, Transcutaneous, For Pain Relief, 2).
Next steps
- See all 17 Neurometrix, Inc. clearances with predicates and recalls
- Run predicate analysis for product code JXE, Neurometrix, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.