510(k) · Cleared
Recalled · Class II · 2020HORIZON TMS Therapy System with Navigation
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magstim Company, Ltd. · OBP Transcranial Magnetic Stimulator
Cleared on Apr 3, 2019 as substantially equivalent to K173620 (Tonica Elektronik A/S, 2018) and 1 other predicate after a 118-day review. Its family tree reaches back 8 generations to 2008. 7 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 3, 2019
- Review
- 118 days
- Class
- Class II
- Product code
- OBP
- Recalls
- 2
- Predicates
- 2
Its longest line of descent runs back 8 generations to DEN070003 (2008). 17 ancestors in all. 7 later devices descend from it, 1 citing it directly.
- Root · 8 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 6 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 5 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 4 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 3 generations backK162935 Rapid2 Therapy SystemMagstim Company, Ltd. · 2017 · Recalled
- 2 generations backK171051 HORIZON Therapy SystemMagstim Company, Ltd. · 2017
- 1 generation backK180907 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · Recalled
- This deviceK183376 HORIZON TMS Therapy System with NavigationMagstim Company, Ltd. · 2019
- Descendant · cites it directly · 6 of its ownK211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2021
- Descendant · 2 generations on · 4 of its ownK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
- Descendant · 3 generations on · 2 of its ownK232235 Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System…The Magstim Company, Ltd. · 2023
- Descendant · 4 generations on · 1 of its ownK241518 Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0…The Magstim Company Limited · 2024
- Descendant · 5 generations on · 0 of its ownK253098 Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj · 2026
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · See all- K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…Magstim Company, Ltd. · 2021 · cites it directly6descendants
- K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…Magstim Company, Ltd. · 2023 · 2 generations on4descendants
- K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0…The Magstim Company, Ltd. · 2023 · 3 generations on2descendants
- K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited · 2024 · 4 generations on1descendant
- K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj · 2026 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −7 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −6 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −5 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −4 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −3 | K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | 2017 | 3 |
| −2 | K171051 | HORIZON Therapy System | Magstim Company, Ltd. | 2017 | — |
| −1 | K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018 | 3 |
| 0 (this device) | K183376 | HORIZON TMS Therapy System with Navigation | Magstim Company, Ltd. | 2019 | — |
| +1 | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0… | Magstim Company, Ltd. | 2021 | — |
| +2 | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0… | Magstim Company, Ltd. | 2023 | — |
| +3 | K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0… | The Magstim Company, Ltd. | 2023 | — |
| +4 | K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS… | The Magstim Company Limited | 2024 | — |
| +5 | K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 5 | 0 |
| 2018 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 1 | 0 |
| 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 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 |
|---|---|---|---|
| * | K173620 | Mag Vita TMS Therapy System w/Theta Burst StimulationSummary page 4…II, product code OBP Additional Product Codes: HAW, IKN Predicate Devices Mag Vita TMS Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S. (K173620) (Primary Predicate) HORIZON® TMS Therapy System, The Magstim Company Limited. (K180907) (Secondary Predicat… | 2018 |
| * | K180907 | HORIZON TMS Therapy SystemSummary page 4…S Therapy System w/Theta Burst Stimulation, Tonica Elektronik A/S. (K173620) (Primary Predicate) HORIZON® TMS Therapy System, The Magstim Company Limited. (K180907) (Secondary Predicate) Nexstim Navigated Brain Therapy (NBT) System 2, Nexstim Plc. (K171902) (Reference Pre… | 2018 |
| † | K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | 2017 |
What descends from it? (7)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0… | 2021 | 6 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2020 | Class II | Z-1965-2020 | Nonconforming Material/Component | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail. |
| Mar 23, 2020 | Class II | Z-1966-2020 | Nonconforming Material/Component | It was identified that there is a potential for the Stim Interconnecting high Voltage Cable located at the rear of the Rapid2 and Horizon power supply unit to fail. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 11 months on median.
- 4 of the 17 ancestors have a recall of any class.
- Of its descendants, K211389 (Magstim Company, Ltd., 2021) has gone furthest, with 6 descendants of its own.
- 8 other devices also cite its predicate K173620.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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?
HORIZON® 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/K183376 · printed Nov 4, 2026
Cite this page
510(k) Report. “K183376: HORIZON TMS Therapy System with Navigation.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K183376
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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