510(k) · Cleared
ClearedNeurosoft TMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Teleemg, LLC · OBP Transcranial Magnetic Stimulator
Cleared on Dec 22, 2016 as substantially equivalent to K150641 (Tonica Elektronik A/S, 2015) and 1 other predicate after a 322-day review. Its family tree reaches back 5 generations to 2008. 46 later devices descend from it.
- Decided
- Dec 22, 2016
- Review
- 322 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 5 generations to DEN070003 (2008). 6 ancestors in all. 46 later devices descend from it, 3 citing it directly.
- Root · 5 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 4 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 3 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 2 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 1 generation backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- This deviceK160309 Neurosoft TMSTeleemg, LLC · 2016
- Descendant · cites it directly · 40 of its ownK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- Descendant · 2 generations on · 39 of its ownK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- Descendant · 2 generations on · 24 of its ownK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- Descendant · 3 generations on · 19 of its ownK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- Descendant · cites it directly · 17 of its ownK173441 Neurosoft TMS (also CloudTMS)Teleemg, LLC · 2017
Showing 5 of 46 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 46 · See all- K171967MagVita TMS Therapy SystemTonica Elektronik A/S · 2017 · cites it directly40descendants
- K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018 · 2 generations on39descendants
- K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020 · 2 generations on24descendants
- K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022 · 3 generations on19descendants
- K173441Neurosoft TMS (also CloudTMS)Teleemg, LLC · 2017 · cites it directly17descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −4 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −3 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −2 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −1 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| 0 (this device) | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| +1 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| +2 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| +2 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| +3 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
| +1 | K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | 2017 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 2 | 0 |
| 2018 | 2 | 0 |
| 2019 | 3 | 0 |
| 2020 | 1 | 0 |
| 2021 | 2 | 0 |
| 2022 | 3 | 0 |
| 2023 | 8 | 0 |
| 2024 | 5 | 0 |
| 2025 | 12 | 0 |
| 2026 | 8 | 0 |
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 K251119 MagVenture TMS Therapy Systemscore 21.8 · 11 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K150641 | MagVita TMS Therapy SystemSummary page 4…MS/D. The two names are fully interchangeable as they represent one and the same product) 3. PREDICATE DEVICES Tonica Electronik A/S, MagVita TMS Therapy System, K150641 Magstim Company Limited, Rapid2 Therapy System, K143531 4. DEVICE DESCRIPTION The Neurosoft TMS is a repetitive transcran… | 2015 |
| * | K143531 | Rapid Therapy SystemSummary page 4…nt one and the same product) 3. PREDICATE DEVICES Tonica Electronik A/S, MagVita TMS Therapy System, K150641 Magstim Company Limited, Rapid2 Therapy System, K143531 4. DEVICE DESCRIPTION The Neurosoft TMS is a repetitive transcranial magnetic stimulation (rTMS) system. This computerized medi… | 2015 |
What descends from it? (46)
See all 463 later devices cite it directly; ranked here by how many devices descend from each in turn.
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 8 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K171967 (Tonica Elektronik A/S, 2017) has gone furthest, with 40 descendants of its own.
- 10 other devices also cite its predicate K150641.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2016, this device’s year, is highlighted.
FDA decisions per year · OBP
12in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · OBP
125in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OBP
1in 2018
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · OBP
81in 2025
MAUDE reports naming product code OBP, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 2 | — | 0 | 0 |
| 2009 | 0 | — | 1 | 3 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 5 |
| 2012 | 0 | — | 0 | 3 |
| 2013 | 2 | — | 0 | 1 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 2 | — | 0 | 3 |
| 2016 | 3 | 101 | 0 | 6 |
| 2017 | 8 | 73 | 0 | 3 |
| 2018 | 4 | 144 | 1 | 6 |
| 2019 | 3 | 156 | 0 | 12 |
| 2020 | 1 | — | 0 | 12 |
| 2021 | 5 | 132 | 0 | 15 |
| 2022 | 6 | 168 | 0 | 59 |
| 2023 | 7 | 119 | 0 | 43 |
| 2024 | 5 | 266 | 0 | 50 |
| 2025 | 12 | 125 | 0 | 81 |
| 2026 | 8 | 176 | 1 | — |
What is it indicated for?
The Neurosoft TMS is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to
receive satisfactory improvement from prior antidepressant medication in the current episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K160309 · printed Nov 6, 2026
Cite this page
510(k) Report. “K160309: Neurosoft TMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K160309
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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