510(k) Report

FDA applicant

Soterix Medical, Inc.

Woodbridge, NJ6 decisions2017–20260 recalls

FDA records 6 decisions for Soterix Medical, Inc. (Woodbridge, NJ) from 2017 to 2026: 6 510(k) clearances. Most are in product codes GWF (Stimulator, Electrical, Evoked Response) and PCC (Stimulator, Nerve, Electrical, Transcutaneous…). Since 2016 its 510(k)s took a median of 231 days from receipt to decision, against 134 for FDA’s reviews in the same codes and years. Its devices cite 7 predicates, 0 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 Soterix Medical, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

2in 2024

2017: 12020: 12021: 12024: 22026 (partial year): 1
2017high 2 (2024) · low 0 (2018)2026

2026 so far, outlined.

Recalls per year

No recall linked to its devices since 2017.

FIG. 1 — Soterix Medical, Inc. by year, 2017–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

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

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Which product codes does it file in?

  • GWFStimulator, Electrical, Evoked Response2decisions
  • PCCStimulator, Nerve, Electrical, Transcutaneous, For Migraine1decision
  • HAWNeurological Stereotaxic Instrument1decision
  • EGJDevice, Iontophoresis, Other Uses1decision
  • OBPTranscranial Magnetic Stimulator1decision

How long do its 510(k) reviews take?

Since 2016, its 4 510(k)s took a median of 231 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 134 days; 1 of its 4 were faster than that.

Whose devices does it build on?

Its devices cite 7 predicates; 0 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 4 times; 0 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.

  • K191422Neural NavigatorSoterix Medical, Inc. · 20204cite it

What has FDA decided for it lately?

  • K251653SPRY TMS Therapy System (0550)Soterix Medical, Inc. · 2026
  • K233751Milieve (YPS-301BD)Soterix Medical, Inc. · 2024
  • K234080MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)Soterix Medical, Inc. · 2024
  • K192823Mega-TMSSoterix Medical, Inc. · 2021
  • K191422Neural NavigatorSoterix Medical, Inc. · 2020
  • K170291IontoDCSoterix Medical, Inc. · 2017

All 6 as Soterix Medical, Inc. →