510(k) Report

FDA applicant

Neurometrix, Inc.

Waltham, MA18 decisions1998–20220 recalls

FDA records 18 decisions for Neurometrix, Inc. (Waltham, MA) from 1998 to 2022: 17 510(k) clearances and 1 De Novo grant. Most are in product codes JXE (Device, Nerve Conduction Velocity Measurement) and GXY (Electrode, Cutaneous). Its devices cite 34 predicates, 22 of them its own earlier devices. No recall is linked to its devices.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, neurology panel, where it files most

How often FDA has decided Neurometrix, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2022

2008: 22009: 32012: 22013: 12014: 22016: 12022: 1
2007high 3 (2009) · low 0 (2007)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2007.

FIG. 1 — Neurometrix, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neurometrix, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • JXEDevice, Nerve Conduction Velocity Measurement7decisions
  • GXYElectrode, Cutaneous4decisions
  • GZJStimulator, Nerve, Transcutaneous, For Pain Relief2decisions
  • NUHStimulator, Nerve, Transcutaneous, Over-The-Counter2decisions
  • QSQTranscutaneous Electrical Nerve Stimulator To Treat Fibromyalgia Symptoms1decision
  • BXNStimulator, Nerve, Battery-Powered1decision

Also: GWL (1).

Whose devices does it build on?

Its devices cite 34 predicates; 22 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 28 times; 22 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K060584NC-StatNeurometrix, Inc. · 20063cite it
  • K013459Modification of NC-StatNeurometrix, Inc. · 20023cite it
  • K982359NC-StatNeurometrix, Inc. · 19983cite it
  • K000565Modification to NC-StatNeurometrix, Inc. · 20003cite it
  • K140333AscendNeurometrix, Inc. · 20143cite it
  • K003508NC-StatNeurometrix, Inc. · 20013cite it

What has FDA decided for it lately?

  • DEN210046Quell-FMNeurometrix, Inc. · 2022
  • K152954QuellNeurometrix, Inc. · 2016
  • K140586Ascend ElectrodeNeurometrix, Inc. · 2014
  • K140333AscendNeurometrix, Inc. · 2014
  • K130919SensusNeurometrix, Inc. · 2013
  • K121816Sensus ElectrodeNeurometrix, Inc. · 2012
  • K121184SensusNeurometrix, Inc. · 2012
  • K091155AscendNeurometrix, Inc. · 2009

All 18 as Neurometrix, Inc. →