510(k) · Cleared
Recalled · Class II · 2020Rapid Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magstim Company Limited · OBP Transcranial Magnetic Stimulator
Cleared on May 8, 2015 as substantially equivalent to K133408 (Neuronetics, 2014) after a 147-day review. Its family tree reaches back 4 generations to 2008. 62 later devices descend from it. It has been recalled 3 times.
- Decided
- May 8, 2015
- Review
- 147 days
- Class
- Class II
- Product code
- OBP
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 4 generations to DEN070003 (2008). 62 later devices descend from it, 7 citing it directly.
- Root · 4 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 3 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 2 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 1 generation backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- This deviceK143531 Rapid Therapy SystemMagstim Company Limited · 2015
- Descendant · cites it directly · 46 of its ownK160309 Neurosoft TMSTeleemg, LLC · 2016
- Descendant · cites it directly · 40 of its ownK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- Descendant · 2 generations on · 39 of its ownK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- Descendant · 2 generations on · 24 of its ownK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- Descendant · 3 generations on · 19 of its ownK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
Showing 5 of 62 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 62 · See all- K160309Neurosoft TMSTeleemg, LLC · 2016 · cites it directly46descendants
- K171967MagVita TMS Therapy SystemTonica Elektronik A/S · 2017 · cites it directly40descendants
- K173620Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018 · 2 generations on39descendants
- K193006MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy systemTonica Elektronik A/S · 2020 · 2 generations on24descendants
- K212289NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy…Neuronetics, Inc. · 2022 · 3 generations on19descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −3 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −2 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −1 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| 0 (this device) | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | — |
| +1 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| +1 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| +2 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| +2 | K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS Therapy system | Tonica Elektronik A/S | 2020 | — |
| +3 | K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced… | Neuronetics, Inc. | 2022 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2016 | 1 | 0 |
| 2017 | 5 | 0 |
| 2018 | 3 | 0 |
| 2019 | 3 | 0 |
| 2020 | 3 | 0 |
| 2021 | 3 | 0 |
| 2022 | 4 | 0 |
| 2023 | 12 | 0 |
| 2024 | 5 | 0 |
| 2025 | 13 | 0 |
| 2026 | 10 | 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 |
|---|---|---|---|
| * | K133408 | Neurostar TMS Therapy SystemSummary page 4…l Magnetic Stimulation (rTMS) System 21 C.F.R. § 882.5805, Class II, product code OBP Predicate Devices NeuroStar TMS Therapy System, Neuronetics, Inc. (K133408) Device Description The Rapid2 Therapy System is a computerized, electromechanical medical device that produces a… | 2014 |
What descends from it? (62)
See all 627 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K160309 | Neurosoft TMS | 2016 | 46 |
| K171967 | MagVita TMS Therapy System | 2017 | 40 |
| K162935 | Rapid2 Therapy System | 2017 | 15 |
| K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | 2017 | 13 |
| K171051 | HORIZON Therapy System | 2017 | 13 |
| K202537 | ALTMS Magnetic Stimulation Therapy System | 2021 | 2 |
| K230735 | Ultimate rTMS; Yingchi rTMS | 2023 | 1 |
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 7 years and passes through 2 companies; a new generation was cleared every 1.1 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K160309 (Teleemg, LLC, 2016) has gone furthest, with 46 descendants of its own.
- 8 other devices also cite its predicate K133408.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 Rapid2 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/K143531 · printed Nov 4, 2026
Cite this page
510(k) Report. “K143531: Rapid 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/K143531
Report an extraction error
Are you the manufacturer?
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