510(k) · Cleared
ClearedHORIZON Therapy System
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 Sep 13, 2017 as substantially equivalent to K143531 (Magstim Company Limited, 2015) and 1 other predicate after a 156-day review. Its family tree reaches back 6 generations to 2008. 13 later devices descend from it.
- Decided
- Sep 13, 2017
- Review
- 156 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 6 generations to DEN070003 (2008). 13 later devices descend from it, 1 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 backK162935 Rapid2 Therapy SystemMagstim Company, Ltd. · 2017 · Recalled
- This deviceK171051 HORIZON Therapy SystemMagstim Company, Ltd. · 2017
- Descendant · cites it directly · 12 of its ownK180907 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · Recalled
- Descendant · 2 generations on · 10 of its ownK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled
- Descendant · 2 generations on · 7 of its ownK183376 HORIZON TMS Therapy System with NavigationMagstim Company, Ltd. · 2019 · Recalled
- Descendant · 3 generations on · 6 of its ownK211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2021
- Descendant · 4 generations on · 4 of its ownK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
Showing 5 of 13 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 13 · See all- K180907HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · cites it directly12descendants
- K182853HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · 2 generations on10descendants
- K183376HORIZON TMS Therapy System with NavigationMagstim Company, Ltd. · 2019 · 2 generations on7descendants
- K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…Magstim Company, Ltd. · 2021 · 3 generations on6descendants
- K222171Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…Magstim Company, Ltd. · 2023 · 4 generations on4descendants
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 | K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | 2017 | 3 |
| 0 (this device) | K171051 | HORIZON Therapy System | Magstim Company, Ltd. | 2017 | — |
| +1 | K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018 | 3 |
| +2 | K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2019 | 2 |
| +2 | K183376 | HORIZON TMS Therapy System with Navigation | Magstim Company, Ltd. | 2019 | 2 |
| +3 | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0… | Magstim Company, Ltd. | 2021 | — |
| +4 | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0… | Magstim Company, Ltd. | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2018 | 1 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2023 | 3 | 0 |
| 2024 | 2 | 0 |
| 2025 | 2 | 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 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 |
|---|---|---|---|
| * | K143531 | Rapid Therapy SystemSummary page 4…timulation (rTMS) System 21 C.F.R. § 882.5805, Class II, product code OBP Predicate Devices Magstim Rapid² Therapy System, The Magstim Company Limited. (K143531 and K162935) Device Description The HORIZON™ Therapy System is a computerized, electromechanical medical device that… | 2015 |
| * | K162935 | Rapid2 Therapy SystemSummary page 4…rTMS) System 21 C.F.R. § 882.5805, Class II, product code OBP Predicate Devices Magstim Rapid² Therapy System, The Magstim Company Limited. (K143531 and K162935) Device Description The HORIZON™ Therapy System is a computerized, electromechanical medical device that produces… | 2017 |
What descends from it? (13)
See all 131 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K180907 | HORIZON TMS Therapy System | 2018 | 12 |
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.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K180907 (Magstim Company, Ltd., 2018) has gone furthest, with 12 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?
The HORIZON™ Therapy System 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/K171051 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171051: HORIZON Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171051
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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