510(k) · Cleared
ClearedLocalite TMS Navigator TS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Localite GmbH · HAW Neurological Stereotaxic Instrument
Cleared on Apr 17, 2023 as substantially equivalent to K191422 (Soterix Medical, Inc., 2020) and 1 other predicate after a 138-day review. Its family tree reaches back 7 generations to 2008. 2 later devices descend from it.
- Decided
- Apr 17, 2023
- Review
- 138 days
- Class
- Class II
- Product code
- HAW
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to DEN070003 (2008). 2 later devices descend from it, 1 citing it directly.
- Root · 7 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 6 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 5 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 4 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 3 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 2 generations backK171902 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2017
- 1 generation backK191422 Neural NavigatorSoterix Medical, Inc. · 2020
- This deviceK223577 Localite TMS Navigator TSLocalite GmbH · 2023
- Descendant · cites it directly · 1 of its ownK251927 Zeta Navigation System (ZNS131-US)Zeta Surgical, Inc. · 2025
- Descendant · 2 generations on · 0 of its ownK261471 Zeta TMS Navigation SystemZeta Surgical, Inc. · 2026
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −6 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −5 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −4 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −3 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −2 | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017 | — |
| −1 | K191422 | Neural Navigator | Soterix Medical, Inc. | 2020 | — |
| 0 (this device) | K223577 | Localite TMS Navigator TS | Localite GmbH | 2023 | — |
| +1 | K251927 | Zeta Navigation System (ZNS131-US) | Zeta Surgical, Inc. | 2025 | — |
| +2 | K261471 | Zeta TMS Navigation System | Zeta Surgical, Inc. | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
| 2026 | 1 | 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? (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 |
|---|---|---|---|
| * | K191422 | Neural NavigatorSummary page 4…ber 882.4560 Product Code HAW I Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K191422 The Neural Navigator HAW K171902 Nexstim Navigated Brain Therapy (NBT) System 2 HAW Device Description Summary 21 CFR 807.92(a)(4… | 2020 |
| * | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2Summary page 4…Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) Predicate # Predicate Trade Name (Primary Predicate is listed first) Product Code K191422 The Neural Navigator HAW K171902 Nexstim Navigated Brain Therapy (NBT) System 2 HAW Device Description Summary 21 CFR 807.92(a)(4) The TMS Navigator TS is a navi… | 2017 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251927 | Zeta Navigation System (ZNS131-US) | 2025 | 1 |
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 15 years and passes through 5 companies; a new generation was cleared every 2.4 years on median.
- 2 of the 7 ancestors have a recall of any class.
- Of its descendants, K251927 (Zeta Surgical, Inc., 2025) has gone furthest, with 1 descendant of its own.
- 3 other devices also cite its predicate K191422.
How does its category compare?
All HAW devicesHAW Neurological Stereotaxic Instrument: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 TMS Navigator TS helps users to plan, implement and document treatment involving TMS of the brain. The system provides planning and navigation functions using anatomical MR data. Regions of the brain to be stimulated can be determined on the basis of anatomy, functional areas or by entering previously calculated coordinates from brain atlases. The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S…
Read the full statement (112 words)
The TMS Navigator TS helps users to plan, implement and document treatment involving TMS of the brain.
The system provides planning and navigation functions using anatomical MR data.
Regions of the brain to be stimulated can be determined on the basis of anatomy, functional areas or by entering
previously calculated coordinates from brain atlases.
The product is intended for use with the MagVenture therapy systems supplied by Tonica Elektronik A/S (Farum,
Denmark), more precisely the R20 and R30 stimulators, the R30 TMS stimulator with MagOption, the X100 stimulator
and the X100 stimulator with MagOption only with following magnetic coils: C-100, C-B60, Cool-B65, Cool-B70, Cool
D-B80, MC-125, MC-B70, MCF-75, MCF-125, MCF-B65 and MMC-140-II.
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/K223577 · printed Nov 4, 2026
Cite this page
510(k) Report. “K223577: Localite TMS Navigator TS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K223577
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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