510(k) · Cleared
Recalled · Class II · 2020Rapid2 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 Mar 10, 2017 as substantially equivalent to K143531 (Magstim Company Limited, 2015) after a 141-day review. Its family tree reaches back 5 generations to 2008. 15 later devices descend from it. It has been recalled 3 times.
- Decided
- Mar 10, 2017
- Review
- 141 days
- Class
- Class II
- Product code
- OBP
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070003 (2008). 15 later devices descend from it, 2 citing it directly.
- Root · 5 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 4 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 3 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 2 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 1 generation backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- This deviceK162935 Rapid2 Therapy SystemMagstim Company, Ltd. · 2017
- Descendant · cites it directly · 13 of its ownK171051 HORIZON Therapy SystemMagstim Company, Ltd. · 2017
- Descendant · 2 generations on · 12 of its ownK180907 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · Recalled
- Descendant · 3 generations on · 10 of its ownK182853 HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · Recalled
- Descendant · 3 generations on · 7 of its ownK183376 HORIZON TMS Therapy System with NavigationMagstim Company, Ltd. · 2019 · Recalled
- Descendant · 4 generations on · 6 of its ownK211389 Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon…Magstim Company, Ltd. · 2021
Showing 5 of 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · See all- K171051HORIZON Therapy SystemMagstim Company, Ltd. · 2017 · cites it directly13descendants
- K180907HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2018 · 2 generations on12descendants
- K182853HORIZON TMS Therapy SystemMagstim Company, Ltd. · 2019 · 3 generations on10descendants
- K183376HORIZON TMS Therapy System with NavigationMagstim Company, Ltd. · 2019 · 3 generations on7descendants
- K211389Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0, Horizon 3.0…Magstim Company, Ltd. · 2021 · 4 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −4 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −3 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −2 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −1 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| 0 (this device) | K162935 | Rapid2 Therapy System | Magstim Company, Ltd. | 2017 | — |
| +1 | K171051 | HORIZON Therapy System | Magstim Company, Ltd. | 2017 | — |
| +2 | K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018 | 3 |
| +3 | K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2019 | 2 |
| +3 | K183376 | HORIZON TMS Therapy System with Navigation | Magstim Company, Ltd. | 2019 | 2 |
| +4 | K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, Horizon 3.0… | Magstim Company, Ltd. | 2021 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 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? (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 |
|---|---|---|---|
| * | K143531 | Rapid Therapy SystemSummary page 4…nial Magnetic Stimulation (rTMS) System 21 C.F.R. § 882.5805, Class Il, product code OBP Predicate Devices Magstim Rapid? Therapy System, The Magstim Company Limited. (K143531) Device Description The Rapid® Therapy System is a computerized, electromechanical medical device that produces and delivers no… | 2015 |
What descends from it? (15)
See all 152 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)
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. |
| Sep 28, 2017 | Class II | Z-1352-2018 | Employee error | Users manuals not supplied with 4800-00T US Rapid Therapy System |
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.
- 2 of the 5 ancestors have a recall of any class.
- Of its descendants, K171051 (Magstim Company, Ltd., 2017) has gone furthest, with 13 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 Rapid® 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K162935 · printed Nov 4, 2026
Cite this page
510(k) Report. “K162935: Rapid2 Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K162935
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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