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 Mar 16, 2023 as substantially equivalent to K220127 (Neuronetics, Inc., 2022) and 1 other predicate after a 161-day review. Its family tree reaches back 10 generations to 2008.
- Decided
- Mar 16, 2023
- Review
- 161 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. No later device cites it as a predicate yet.
- 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 deviceK223154 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
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 deviceK223154 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2023
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) | K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, H3.0… | Magstim Company, Ltd. | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 0 |
| 2017 | 5 | 0 |
| 2018 | 2 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar…Summary page 4…stem for Neurological and Psychiatric Disorders and Conditions Classification 21 C.F.R. § 882.5805, Class II, product code OBP Predicate Devices K220127 NeuroStar Advanced Therapy, Neuronetics Inc. (Primary Predicate Device), 21 C.F.R § 882.5805, OBP K211389 Horizon®… | 2022 |
| * | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…Summary page 4…s II, product code OBP Predicate Devices K220127 NeuroStar Advanced Therapy, Neuronetics Inc. (Primary Predicate Device), 21 C.F.R § 882.5805, OBP K211389 Horizon® 3.0 TMS Therapy System, The Magstim® Company Limited (Secondary P Predicate D… | 2021 |
What descends from it?
No later submission names this one as a predicate yet.
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.
- 4 other devices also cite its predicate K220127.
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 depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and 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/K223154 · printed Nov 6, 2026
Cite this page
510(k) Report. “K223154: 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 6, 2026. https://510kreport.com/device/K223154
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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