510(k) Report

FDA applicant

Neuronetics, Inc.

Malvern, PA15 decisions2008–20242 recalls

FDA records 15 decisions for Neuronetics, Inc. (Malvern, PA) from 2008 to 2024: 14 510(k) clearances and 1 De Novo grant. Most are in product codes OBP (Transcranial Magnetic Stimulator) and QCI (Transcranial Magnetic Stimulation System For…). Since 2016 its 510(k)s took a median of 88 days from receipt to decision, against 119 for FDA’s reviews in the same codes and years. Its devices cite 55 predicates, 53 of them its own earlier devices. 2 recalls are linked to its devices.

FDA’s records also spell it “Neuronetics”.

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 Neuronetics, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2024

2008: 22013: 12014: 12016: 22020: 12021: 12022: 32023: 32024: 1
2008high 3 (2022) · low 0 (2009)2026

2026 so far, outlined.

Recalls per year

1in 2026

2009: 12026 (partial year): 1
2008high 1 (2009) · low 0 (2008)2026

Class I Class II/III not classified

FIG. 1 — Neuronetics, Inc. by year, 2008–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Neuronetics, 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?

  • OBPTranscranial Magnetic Stimulator13decisions
  • QCITranscranial Magnetic Stimulation System For Obsessive-Compulsive Disorder2decisions

How long do its 510(k) reviews take?

Since 2016, its 9 510(k)s took a median of 88 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 119 days; 5 of its 9 were faster than that.

Whose devices does it build on?

Its devices cite 55 predicates; 53 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 70 times; 53 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.

  • K133408Neurostar TMS Therapy SystemNeuronetics · 20149cite it
  • K083538Neurostar TMS Therapy System, Model 1.1Neuronetics · 20089cite it
  • K160703NeuroStar TMS Therapy SystemNeuronetics, Inc. · 20168cite it
  • K161519NeuroStar TMS Therapy SystemNeuronetics, Inc. · 20167cite it
  • DEN070003Neurostar TMS SystemNeuronetics · 20086cite it
  • K130233Neurostar TMS Therapy SystemNeuronetics · 20136cite it

What has FDA decided for it lately?

  • K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 20241 recall
  • K233621NeuroStar Advanced Therapy System (Version 3.8)Neuronetics · 20231 recall
  • K231350OCD MT Cap (85-00397-000)Neuronetics · 2023
  • K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
  • K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022
  • K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for…Neuronetics, Inc. · 2022
  • K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS…Neuronetics, Inc. · 2022
  • K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for…Neuronetics, Inc. · 2021

All 8 as Neuronetics, Inc. →All 7 as Neuronetics →

What has been recalled?

2 recalls linked to its devices; the latest:

  • K231926NeuroStar Advanced Therapy System. Contains the NeuroStar HP Coil Assembly Part Number…Aug 24, 2026Class II
  • K083538NeuroStar TMS Therapy System/SenStar Treatment Link. The SenStar Treatment Link is a…Mar 16, 2009