510(k) · Cleared
ClearedMagstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+
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 Jan 13, 2023 as substantially equivalent to K212289 (Neuronetics, Inc., 2022) and 1 other predicate after a 176-day review. Its family tree reaches back 10 generations to 2008. 4 later devices descend from it.
- Decided
- Jan 13, 2023
- Review
- 176 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 10 generations to DEN070003 (2008). 26 ancestors in all. 4 later devices descend from it, 2 citing it directly.
- Root · 10 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 6 generations between
- 3 generations backK180907 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · Recalled
- 2 generations backK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled
- 1 generation backK211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2021
- This deviceK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
- Descendant · cites it directly · 2 of its ownK232235 Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System…The Magstim Company, Ltd. · 2023
- Descendant · 2 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 · 3 generations on · 0 of its ownK253098 Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj · 2026
- Descendant · cites it directly · 0 of its ownK243539 Apollo TMS Therapy SystemMag & More GmbH · 2025
Show all 10 generations
- Root · 10 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 9 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 8 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 7 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 6 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 5 generations backK162935 Rapid2 Therapy SystemMagstim Company, Ltd. · 2017 · Recalled
- 4 generations backK171051 HORIZON Therapy SystemMagstim Company, Ltd. · 2017
- 3 generations backK180907 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · Recalled
- 2 generations backK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled
- 1 generation backK211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2021
- This deviceK222171 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
Most influential descendants
Showing 4 of 4 · See all- K232235Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0; Horizon® 3.0…The Magstim Company, Ltd. · 2023 · cites it directly2descendants
- K241518Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS Therapy System…The Magstim Company Limited · 2024 · 2 generations on1descendant
- K253098Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)Nexstim Oyj · 2026 · 3 generations on0descendants
- K243539Apollo TMS Therapy SystemMag & More GmbH · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −10 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −9 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −8 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −7 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −6 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −5 | K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | 2017 | 3 |
| −4 | K171051 | HORIZON Therapy System | Magstim Company, Ltd. | 2017 | — |
| −3 | K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018 | 3 |
| −2 | K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2019 | 2 |
| −1 | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0… | Magstim Company, Ltd. | 2021 | — |
| 0 (this device) | K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0… | Magstim Company, Ltd. | 2023 | — |
| +1 | K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System; Horizon® 3.0… | The Magstim Company, Ltd. | 2023 | — |
| +2 | K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horizon® 3.0 TMS… | The Magstim Company Limited | 2024 | — |
| +3 | K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026 | — |
| +1 | K243539 | Apollo TMS Therapy System | Mag & More GmbH | 2025 | — |
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 |
|---|---|---|
| 2023 | 1 | 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 |
|---|---|---|---|
| * | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Summary page 4…Conditions Classification 21 C.F.R. § 882.5805, Class II, product code OBP 21 C.F.R. § 882.5802, Class II, product code QCI Predicate Devices K212289 NeuroStar Advanced Therapy, Neuronetics Inc. (Primary Predicate Device), 21 C.F.R § 882.5802, QCI K211389 Horizon®… | 2022 |
| * | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…Summary page 4…ss II, product code QCI Predicate Devices K212289 NeuroStar Advanced Therapy, Neuronetics Inc. (Primary Predicate Device), 21 C.F.R § 882.5802, QCI K211389 Horizon® 3.0 TMS Therapy System, The Magstim® Company Limited (Secondary Predicate Device ), 21 C.F.R § 882.5805, OBP… | 2021 |
| † | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | 2020 |
What descends from it? (4)
2 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 15 years and passes through 3 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 26 ancestors have a recall of any class.
- Of its descendants, K232235 (The Magstim Company, Ltd., 2023) has gone furthest, with 2 descendants of its own.
- 3 other devices also cite its predicate K212289.
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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K222171 · printed Nov 4, 2026
Cite this page
510(k) Report. “K222171: Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0, Horizon 3.0 with StimGuide+.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K222171
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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