510(k) Report

510(k) · Cleared

Cleared

NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health

K222230510(k) SpecialCleared Aug 24, 202230-day reviewClass II21 CFR 882.5805

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Neuronetics, Inc. · OBP Transcranial Magnetic Stimulator

Cleared on Aug 24, 2022 as substantially equivalent to K083538 (Neuronetics, 2008) and 7 other predicates after a 30-day review. Its family tree reaches back 8 generations to 2008.

Decided
Aug 24, 2022
Review
30 days
Class
Class II
Product code
OBP
Recalls
None
Predicates
8

Its longest line of descent runs back 8 generations to DEN070003 (2008). 12 ancestors in all. No later device cites it as a predicate yet.

Other ancestors, by year cleared 2022: 1 other ancestor2021: 1 other ancestor2018: 1 other ancestor2013: 1 other ancestor×2: 2 generations cleared close together, DEN070003 (2008), K083538 (2008) K130233 · Neurostar TMS Therapy System · Neuronetics · 2013K133408 · Neurostar TMS Therapy System · Neuronetics · 2014K160703 · NeuroStar TMS Therapy System · Neuronetics, Inc. · 2016K161519 · NeuroStar TMS Therapy System · Neuronetics, Inc. · 2016K201158 · NeuroStar Advanced Therapy · Neuronetics, Inc. · 2020K213543 · NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health · Neuronetics, Inc. · 20212005201020152020
Other ancestors, by generation 1 generation back: 1 other ancestor2 generations back: 1 other ancestor3 generations back: 2 other ancestors K213543 · NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health · Neuronetics, Inc. · 2021K201158 · NeuroStar Advanced Therapy · Neuronetics, Inc. · 2020K161519 · NeuroStar TMS Therapy System · Neuronetics, Inc. · 2016K160703 · NeuroStar TMS Therapy System · Neuronetics, Inc. · 2016K133408 · Neurostar TMS Therapy System · Neuronetics · 2014K130233 · Neurostar TMS Therapy System · Neuronetics · 2013K083538 · Neurostar TMS Therapy System, Model 1.1 · Neuronetics · 2008 · recalledDEN070003 · Neurostar TMS System · Neuronetics · 2008−50
  1. Root · 8 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
  2. 7 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
  3. 6 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
  4. 5 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
  5. 4 generations backK160703 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
  6. 3 generations backK161519 NeuroStar TMS Therapy SystemNeuronetics, Inc. · 2016
  7. 2 generations backK201158 NeuroStar Advanced TherapyNeuronetics, Inc. · 2020
  8. 1 generation backK213543 NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System…Neuronetics, Inc. · 2021
  9. This deviceK222230 NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8DEN070003Neurostar TMS SystemNeuronetics2008—
−7K083538Neurostar TMS Therapy System, Model 1.1Neuronetics20081
−6K130233Neurostar TMS Therapy SystemNeuronetics2013—
−5K133408Neurostar TMS Therapy SystemNeuronetics2014—
−4K160703NeuroStar TMS Therapy SystemNeuronetics, Inc.2016—
−3K161519NeuroStar TMS Therapy SystemNeuronetics, Inc.2016—
−2K201158NeuroStar Advanced TherapyNeuronetics, Inc.2020—
−1K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar…Neuronetics, Inc.2021—
0 (this device)K222230NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System…Neuronetics, Inc.2022—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201310
201810
202110
202210
FIG. 1 — Lineage of K222230, 2008–2022Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.

Planning a device in OBP? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.

Top candidate predicates for a new OBP device

  1. #1 K251119 MagVenture TMS Therapy Systemscore 21.8 · 11 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (8)

Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.

TypeNumberDeviceApplicantDecidedRecalls
*K083538Neurostar TMS Therapy System, Model 1.1
Summary page 4
…mmon Name: Transcranial Magnetic Stimulator Classification: 21 CFR 882.5805 Product Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127)…
Neuronetics20081
*K130233Neurostar TMS Therapy System
Summary page 4
…: Transcranial Magnetic Stimulator Classification: 21 CFR 882.5805 Product Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127)…
Neuronetics2013—
*K133408Neurostar TMS Therapy System
Summary page 4
…lator Classification: 21 CFR 882.5805 Product Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127)…
Neuronetics2014—
*K160703NeuroStar TMS Therapy System
Summary page 4
…assification: 21 CFR 882.5805 Product Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127) Page 1 o…
Neuronetics, Inc.2016—
*K161519NeuroStar TMS Therapy System
Summary page 4
…ion: 21 CFR 882.5805 Product Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127) Page 1 of 8 ===…
Neuronetics, Inc.2016—
*K201158NeuroStar Advanced Therapy
Summary page 4
…21 CFR 882.5805 Product Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127) Page 1 of 8 === Page 5 ==…
Neuronetics, Inc.2020—
*K213543NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…
Summary page 4
…882.5805 Product Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127) Page 1 of 8 Device…
Neuronetics, Inc.2021—
*K220127NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…
Summary page 4
…duct Code: OBP Predicate Device: NeuroStar Advanced Therapy System (K083538, K130233, K133408, K160703, K161519, K201158, K213543, and K220127) Page 1 of 8 Device Description /…
Neuronetics, Inc.2022—

Also cleared against K083538: 8 other devices →

What descends from it?

No later submission names this one as a predicate yet.

Has anything in its family been recalled? (0 Class I)

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 14 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
  • 1 of the 12 ancestors has a recall of any class.
  • 8 other devices also cite its predicate K083538.

How does its category compare?

All OBP devices

OBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, this device’s year, is highlighted.

FDA decisions per year · OBP

12in 2025

2008: 22013: 22014: 12015: 22016: 32017: 82018: 42019: 32020: 12021: 52022: 62023: 72024: 52025: 122026 (partial year): 8
2007high 12 (2025) · low 0 (2007)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · OBP

125in 2025

2016: 101 days median2017: 73 days median2018: 144 days median2019: 156 days median2021: 132 days median2022: 168 days median2023: 119 days median2024: 266 days median2025: 125 days median2026 (partial year): 176 days median
2007high 266 (2024) · low 73 (2017)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · OBP

1in 2018

2009: 12018: 12026 (partial year): 1
2007high 1 (2009) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · OBP

81in 2025

2009: 32011: 52012: 32013: 12015: 32016: 62017: 32018: 62019: 122020: 122021: 152022: 592023: 432024: 502025: 81
2007high 81 (2025) · low 0 (2007)2025

MAUDE reports naming product code OBP, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20070—00
20082—00
20090—13
20100—00
20110—05
20120—03
20132—01
20141—00
20152—03
2016310106
201787303
2018414416
20193156012
20201—012
20215132015
20226168059
20237119043
20245266050
202512125081
202681761—

What is it indicated for?

The NeuroStar Advanced Therapy System is indicated for the treatment of depressive episodes and

for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult

patients suffering from Major Depressive Disorder (MDD) and who failed to achieve satisfactory

improvement from previous antidepressant medication treatment in the current episode.

Indications for use as stated in the FDA summary.

Also cleared against K083538

8 other devices cite the same predicate.

  • K233621NeuroStar Advanced Therapy System (Version 3.8)Neuronetics · 20231 recall
  • K230029NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
  • 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
  • K150641MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
  • K133408Neurostar TMS Therapy SystemNeuronetics · 2014

More from Neuronetics, Inc.

8 FDA decisions under this applicant name. See the company

  • K231926NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 20241 recall
  • 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
  • K201158NeuroStar Advanced TherapyNeuronetics, Inc. · 2020

Recent decisions in OBP

The OBP category page

  • K260396KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)Fidelity BioPharma Co. · 2026
  • K260691BTL-699BTL Industries, Inc. · 2026
  • K261228QuickVision Ultimate rTMSBrain Ultimate, Inc. · 2026
  • K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH · 2026
  • K260189MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026

https://510kreport.com/device/K222230 · printed Nov 4, 2026

Cite this page

510(k) Report. “K222230: NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222230

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Record history
  • FDA decision record loaded May 2, 2026
  • Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
  • Lineage and recalls computed Nov 3, 2026
  • Page last updated Nov 3, 2026