510(k) · Cleared
ClearedALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Remed Co., Ltd. · OBP Transcranial Magnetic Stimulator
Cleared on Apr 6, 2022 as substantially equivalent to K202537 (Remed Co., Ltd., 2021) and 1 other predicate after a 34-day review. Its family tree reaches back 7 generations to 2008. 1 later device descends from it.
- Decided
- Apr 6, 2022
- Review
- 34 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 7 generations to DEN070003 (2008). 11 ancestors in all. 1 later device descends from it, 1 citing it directly.
- Root · 7 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 6 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 5 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 4 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 3 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 2 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 1 generation backK173441 Neurosoft TMS (also CloudTMS)Teleemg, LLC · 2017
- This deviceK220625 ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemRemed Co., Ltd. · 2022
- Descendant · cites it directly · 0 of its ownK251653 SPRY TMS Therapy System (0550)Soterix Medical, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K251653SPRY TMS Therapy System (0550)Soterix Medical, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −6 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −5 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −4 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −3 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −2 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −1 | K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | 2017 | — |
| 0 (this device) | K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System | Remed Co., Ltd. | 2022 | — |
| +1 | K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2021 | 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? (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 |
|---|---|---|---|
| * | K202537 | ALTMS Magnetic Stimulation Therapy SystemSummary page 4…I Regulation Number: 882.5805 Classification Panel: Neurology III. Predicate Information ALTMS Magnetic Stimulation Therapy System (REDMED Co., Ltd. K202537) Primary predicate device Neurosoft TMS (TeleEMG, LLC. K173441) Reference device IV. Device Description The ALTM… | 2021 |
| * | K173441 | Neurosoft TMS (also CloudTMS)Summary page 4…Predicate Information ALTMS Magnetic Stimulation Therapy System (REDMED Co., Ltd. K202537) Primary predicate device Neurosoft TMS (TeleEMG, LLC. K173441) Reference device IV. Device Description The ALTMS Magnetic Stimulation Therapy System (also Blossom TMS Therapy System)… | 2017 |
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 |
|---|---|---|---|
| K251653 | SPRY TMS Therapy System (0550) | 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 14 years and passes through 4 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 11 ancestors have a recall of any class.
- Of its descendants, K251653 (Soterix Medical, Inc., 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?
ALTMS Magnetic Stimulation Therapy System (also Blossom 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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K220625 · printed Nov 6, 2026
Cite this page
510(k) Report. “K220625: ALTMS Magnetic Stimulation Therapy System, Blossom 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/K220625
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