510(k) · Cleared
ClearedMagstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
The Magstim Company, Ltd. · OBP Transcranial Magnetic Stimulator
Cleared on Oct 25, 2023 as substantially equivalent to K222171 (Magstim Company, Ltd., 2023) after a 90-day review. Its family tree reaches back 11 generations to 2008. 2 later devices descend from it.
- Decided
- Oct 25, 2023
- Review
- 90 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 11 generations to DEN070003 (2008). 27 ancestors in all. 2 later devices descend from it, 1 citing it directly.
- Root · 11 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations between
- 3 generations backK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled
- 2 generations backK211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2021
- 1 generation backK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
- This deviceK232235 Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System…The Magstim Company, Ltd. · 2023
- Descendant · cites it directly · 1 of its ownK241518 Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0…The Magstim Company Limited · 2024
- Descendant · 2 generations on · 0 of its ownK253098 Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj · 2026
Show all 11 generations
- Root · 11 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 10 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 9 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 8 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 7 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 6 generations backK162935 Rapid2 Therapy SystemMagstim Company, Ltd. · 2017 · Recalled
- 5 generations backK171051 HORIZON Therapy SystemMagstim Company, Ltd. · 2017
- 4 generations backK180907 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · Recalled
- 3 generations backK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled
- 2 generations backK211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2021
- 1 generation backK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
- This deviceK232235 Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System…The Magstim Company, Ltd. · 2023
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 |
|---|---|---|---|---|---|
| −11 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −10 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −9 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −8 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −7 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −6 | K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | 2017 | 3 |
| −5 | K171051 | HORIZON Therapy System | Magstim Company, Ltd. | 2017 | — |
| −4 | K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018 | 3 |
| −3 | K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2019 | 2 |
| −2 | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0… | Magstim Company, Ltd. | 2021 | — |
| −1 | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0… | Magstim Company, Ltd. | 2023 | — |
| 0 (this device) | K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0… | The Magstim Company, Ltd. | 2023 | — |
| +1 | K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS… | The Magstim Company Limited | 2024 | — |
| +2 | 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 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 2 | 0 |
| 2020 | 2 | 0 |
| 2022 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2024 | 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? (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 |
|---|---|---|---|
| * | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon…Summary page 5…82.5802, Class II, subsequent product code QCI Predicate Devices Primary Predicate Device: Horizon 3.0® TMS Therapy System, The Magstim® Company Limited (K222171) Product Code: 21 C.F.R. § 882.5805 OBP, Subsequent Product Code: 21 C.F.R. § 882.5802 QCI Device Description… | 2023 |
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 |
|---|---|---|---|
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System… | 2024 | 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 4 companies; a new generation was cleared every 11 months on median.
- 6 of the 27 ancestors have a recall of any class.
- Of its descendants, K241518 (The Magstim Company Limited, 2024) has gone furthest, with 1 descendant of its own.
- 1 other device also cites its predicate K222171.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2023, 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 3.0 TMS 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, as well as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K232235 · printed Nov 4, 2026
Cite this page
510(k) Report. “K232235: Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0 with Navigation; Horizon® 3.0 with StimGuide Pro.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K232235
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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