510(k) · Cleared
ClearedNeural Navigator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soterix Medical, Inc. · HAW Neurological Stereotaxic Instrument
Cleared on Apr 6, 2020 as substantially equivalent to K171902 (Nexstim Plc, 2017) after a 313-day review. Its family tree reaches back 6 generations to 2008. 8 later devices descend from it.
- Decided
- Apr 6, 2020
- Review
- 313 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to DEN070003 (2008). 8 later devices descend from it, 4 citing it directly.
- Root · 6 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 5 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 4 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 3 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 2 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 1 generation backK171902 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2017
- This deviceK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- Descendant · cites it directly · 2 of its ownK223577 Localite TMS Navigator TSLocalite GmbH · 2023
- Descendant · 2 generations on · 1 of its ownK251927 Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025
- Descendant · cites it directly · 1 of its ownK210109 visor2 systemEemagine Medical Imaging Solutions GmbH · 2022
- Descendant · cites it directly · 1 of its ownK201035 ETHICON Linx Esophagus Sizing ToolTorax Medical, Inc. · 2020
- Descendant · 2 generations on · 0 of its ownK261228 QuickVision Ultimate rTMSBrain Ultimate, Inc. · 2026
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K223577Localite TMS Navigator TSLocalite GmbH · 2023 · cites it directly2descendants
- K251927Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025 · 2 generations on1descendant
- K210109visor2 systemEemagine Medical Imaging Solutions GmbH · 2022 · cites it directly1descendant
- K201035ETHICON Linx Esophagus Sizing ToolTorax Medical, Inc. · 2020 · cites it directly1descendant
- K261228QuickVision Ultimate rTMSBrain Ultimate, Inc. · 2026 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −5 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −4 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −3 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −2 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −1 | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017 | — |
| 0 (this device) | K191422 | Neural Navigator | Soterix Medical, Inc. | 2020 | — |
| +1 | K223577 | Localite TMS Navigator TS | Localite GmbH | 2023 | — |
| +2 | K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2025 | — |
| +1 | K210109 | visor2 system | Eemagine Medical Imaging Solutions GmbH | 2022 | — |
| +1 | K201035 | ETHICON Linx Esophagus Sizing Tool | Torax Medical, Inc. | 2020 | — |
| +2 | K261228 | QuickVision Ultimate rTMS | Brain Ultimate, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2020 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 3 | 0 |
| 2025 | 1 | 0 |
| 2026 | 2 | 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 HAW? 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 HAW device
- #1 K253856 Geniant Cranial (Navigated Neurosurgical…score 15.0 · 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 |
|---|---|---|---|
| * | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2Summary page 4…HAW - Stereotaxic Instrument (21 CFR 882.4560) Device Class: Class II Predicate Devices: 1. Nexstim Navigated Brain Therapy (NBT) System 2 (K171902) Nexstim Plc Class II (Primary Predicate)… | 2017 |
| † | K112881 | Nexstim Navigated Brain Stimulation (NBS) System 4, Nexstim NBS System 4 with Nexspeech… | 2012 |
What descends from it? (8)
4 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 12 years and passes through 4 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 6 ancestors have a recall of any class.
- Of its descendants, K223577 (Localite GmbH, 2023) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K171902.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2020, this device’s year, is highlighted.
FDA decisions per year · HAW
9in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · HAW
163in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · HAW
2in 2025
Class I (9 since 2007) Class II/III not classified
Adverse event reports per year · HAW
3,425in 2025
MAUDE reports naming product code HAW, 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 | 15 | 107 | 2 | 49 |
| 2008 | 12 | 112 | 10 | 53 |
| 2009 | 8 | 221 | 6 | 96 |
| 2010 | 6 | 138 | 28 | 299 |
| 2011 | 4 | 66 | 5 | 1,725 |
| 2012 | 8 | 178 | 4 | 986 |
| 2013 | 3 | 172 | 6 (1) | 1,290 |
| 2014 | 5 | 238 | 5 | 1,606 |
| 2015 | 10 | 232 | 3 | 1,767 |
| 2016 | 9 | 175 | 5 | 1,828 |
| 2017 | 7 | 226 | 2 | 3,505 |
| 2018 | 6 | 112 | 2 (2) | 4,439 |
| 2019 | 10 | 147 | 4 (1) | 6,062 |
| 2020 | 5 | 88 | 1 | 3,480 |
| 2021 | 9 | 168 | 4 (2) | 2,827 |
| 2022 | 7 | 128 | 1 | 1,929 |
| 2023 | 14 | 142 | 4 (1) | 2,510 |
| 2024 | 7 | 107 | 2 (2) | 3,755 |
| 2025 | 9 | 163 | 2 | 3,425 |
| 2026 | 5 | 162 | 6 | — |
What is it indicated for?
The Neural Navigator is a neuronavigation system indicated for accurate positioning of the treatment coil of the CloudTMS Therapy System with respect to target brain regions based on data obtained from MRI measurements. Specifically, the Neural Navigator is indicated for use with the following CloudTMS Therapy System coils manufactured by Neurosoft Ltd: AFEC-02-100 and AFEC-02-100-C.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K191422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K191422: Neural Navigator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K191422
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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