510(k) · Cleared
ClearedNexstim Navigated Brain Therapy (NBT) System 2
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Nexstim Plc · OBP Transcranial Magnetic Stimulator
Cleared on Nov 10, 2017 as substantially equivalent to K143531 (Magstim Company Limited, 2015) after a 137-day review. Its family tree reaches back 5 generations to 2008. 13 later devices descend from it.
- Decided
- Nov 10, 2017
- Review
- 137 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070003 (2008). 13 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 deviceK171902 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2017
- Descendant · cites it directly · 8 of its ownK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- Descendant · cites it directly · 3 of its ownK182700 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2019
- Descendant · cites it directly · 2 of its ownK223577 Localite TMS Navigator TSLocalite GmbH · 2023
- Descendant · 2 generations on · 2 of its ownK220177 Magnus Neuromodulation System (MNS) with SAINT Technology, Model…Magnus Medical, Inc. · 2022
- Descendant · 2 generations on · 1 of its ownK251927 Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K191422Neural NavigatorSoterix Medical, Inc. · 2020 · cites it directly8descendants
- K182700Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2019 · cites it directly3descendants
- K223577Localite TMS Navigator TSLocalite GmbH · 2023 · cites it directly2descendants
- K220177Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001KMagnus Medical, Inc. · 2022 · 2 generations on2descendants
- K251927Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025 · 2 generations on1descendant
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) | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017 | — |
| +1 | K191422 | Neural Navigator | Soterix Medical, Inc. | 2020 | — |
| +1 | K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2019 | — |
| +1 | K223577 | Localite TMS Navigator TS | Localite GmbH | 2023 | — |
| +2 | K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K | Magnus Medical, Inc. | 2022 | — |
| +2 | K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2019 | 1 | 0 |
| 2020 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 3 | 0 |
| 2025 | 2 | 0 |
| 2026 | 3 | 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? (1)
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 |
|---|---|---|---|
| * | K143531 | Rapid Therapy SystemSummary page 4…ly New Model Predicate Predicate Equivalent Devices: 510(k) Number Manufacturer / Model Nexstim K143531 Magstim Company Limited / Rapid2 Therapy Navigated System (Primary Predicate… | 2015 |
| † | K112881 | Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with Nexspeech… | 2012 |
| † | K162935 | Rapid2 Therapy System | 2017 |
| † | K133408 | Neurostar TMS Therapy System | 2014 |
| † | K150641 | MagVita TMS Therapy System | 2015 |
What descends from it? (13)
See all 133 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 9 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K191422 (Soterix Medical, Inc., 2020) has gone furthest, with 8 descendants of its own.
- 6 other devices also cite its predicate K143531.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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?
Nexstim Navigated Brain Therapy (NBT) System 2 is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K171902 · printed Nov 5, 2026
Cite this page
510(k) Report. “K171902: Nexstim Navigated Brain Therapy (NBT) System 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K171902
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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