510(k) · Cleared
ClearedApollo TMS Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Mag & More GmbH · OBP Transcranial Magnetic Stimulator
Cleared on Sep 4, 2025 as substantially equivalent to K231926 (Neuronetics, Inc., 2024) and 2 other predicates after a 279-day review. Its family tree reaches back 12 generations to 2008. 1 later device descends from it.
- Decided
- Sep 4, 2025
- Review
- 279 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 12 generations to DEN070003 (2008). 32 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 12 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 8 generations between
- 3 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 2 generations backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- 1 generation backK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- This deviceK243700 Apollo TMS Therapy SystemMag & More GmbH · 2025
- Descendant · cites it directly · 0 of its ownK260560 Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH · 2026
Show all 12 generations
- Root · 12 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 11 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 10 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 9 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 8 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 7 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 6 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 5 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 4 generations backK193006 MagVenture TMS Therapy – for treatment of OCD, MagVenture TMS…Tonica Elektronik A/S · 2020
- 3 generations backK212289 NeuroStar Advanced Therapy for adjunctive treatment of OCD…Neuronetics, Inc. · 2022
- 2 generations backK230029 NeuroStar Advanced Therapy System (Version 3.7)Neuronetics · 2023
- 1 generation backK231926 NeuroStar Advanced Therapy System (All previously cleared models)Neuronetics, Inc. · 2024 · Recalled
- This deviceK243700 Apollo TMS Therapy SystemMag & More GmbH · 2025
Most influential descendants
Showing 1 of 1 · See all- K260560Apollo TMS Therapy System;Apollo light TMS Therapy SystemMag & More GmbH · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −11 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −10 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −9 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −8 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −7 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −6 | K171967 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −5 | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018 | — |
| −4 | 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 | — |
| −2 | K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023 | — |
| −1 | K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | Neuronetics, Inc. | 2024 | 1 |
| 0 (this device) | K243700 | Apollo TMS Therapy System | Mag & More GmbH | 2025 | — |
| +1 | K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 2 | 0 |
| 2017 | 6 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2020 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (3)
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 |
|---|---|---|---|
| * | K231926 | NeuroStar Advanced Therapy System (All previously cleared models)Summary page 5…Stimulation Device 21 CFR 882.5805, Product Code OBP Predicate Device: NeuroStar Advanced Therapy System (K231926) Apollo TMS Therapy System (K180313, K232639) Intended Use The Apollo TMS Therapy Sys… | 2024 |
| * | K180313 | Apollo TMS Therapy SystemSummary page 5…Product Code OBP Predicate Device: NeuroStar Advanced Therapy System (K231926) Apollo TMS Therapy System (K180313, K232639) Intended Use The Apollo TMS Therapy System is indicated for the treatment of major depressive disorder (MDD) in adu… | 2018 |
| * | K232639 | Apollo TMS Therapy SystemSummary page 5…Code OBP Predicate Device: NeuroStar Advanced Therapy System (K231926) Apollo TMS Therapy System (K180313, K232639) Intended Use The Apollo TMS Therapy System is indicated for the treatment of major depressive disorder (MDD) in adult patien… | 2024 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | 2026 | 0 |
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 17 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 6 of the 32 ancestors have a recall of any class.
- Of its descendants, K260560 (Mag & More GmbH, 2026) has gone furthest, with 0 descendants of its own.
- 3 other devices also cite its predicate K231926.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2025, 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 Apollo 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 and as an adjunct for the treatment of MDD in adolescent patients (age 15-21).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K243700 · printed Nov 6, 2026
Cite this page
510(k) Report. “K243700: Apollo TMS Therapy System.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K243700
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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