510(k) · Cleared
ClearedMagnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Magnus Medical, Inc. · OBP Transcranial Magnetic Stimulator
Cleared on Sep 1, 2022 as substantially equivalent to K182700 (Nexstim Plc, 2019) after a 223-day review. Its family tree reaches back 9 generations to 2008. 2 later devices descend from it.
- Decided
- Sep 1, 2022
- Review
- 223 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to DEN070003 (2008). 15 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 9 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 5 generations between
- 3 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 2 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 1 generation backK182700 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2019
- This deviceK220177 Magnus Neuromodulation System (MNS) with SAINT Technology, Model…Magnus Medical, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260189 MagVenture Accelerated TMS (aTMS) Therapy SystemTonica Elektronik A/S · 2026
- Descendant · cites it directly · 0 of its ownK251449 BrainsWay Deep TMS SystemBrainsway, Ltd. · 2025
Show all 9 generations
- Root · 9 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 8 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 7 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 6 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 5 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 4 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 3 generations backK171967 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 2 generations backK173620 Mag Vita TMS Therapy System w/Theta Burst StimulationTonica Elektronik A/S · 2018
- 1 generation backK182700 Nexstim Navigated Brain Therapy (NBT) System 2Nexstim Plc · 2019
- This deviceK220177 Magnus Neuromodulation System (MNS) with SAINT Technology, Model…Magnus Medical, Inc. · 2022
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −8 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −7 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −6 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −5 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −4 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −3 | 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 | — |
| −1 | K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2019 | — |
| 0 (this device) | K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K | Magnus Medical, Inc. | 2022 | — |
| +1 | K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | 2026 | — |
| +1 | K251449 | BrainsWay Deep TMS System | Brainsway, Ltd. | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K182700 | Nexstim Navigated Brain Therapy (NBT) System 2Summary page 4…tem 2 Nexstim Plc Helsinki, Finland Premarket Notification K182700 Cleared on March 22, 2019 Device Description: The Magnus Neuromodulation S… | 2019 |
| † | K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | 2018 |
What descends from it? (2)
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 14 years and passes through 6 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 15 ancestors have a recall of any class.
- Of its descendants, K260189 (Tonica Elektronik A/S, 2026) has gone furthest, with 0 descendants of its own.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2022, 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 Magnus Neuromodulation System with SAINT Technology is indicated for the treatment of Major Depressive Disorder (MDD) 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/K220177 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220177: Magnus Neuromodulation System (MNS) with SAINT Technology, Model Number 1001K.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K220177
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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