510(k) · Cleared
ClearedSPRY TMS Therapy System (0550)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Soterix Medical, Inc. · OBP Transcranial Magnetic Stimulator
Cleared on Feb 20, 2026 as substantially equivalent to K220625 (Remed Co., Ltd., 2022) after a 267-day review. Its family tree reaches back 8 generations to 2008.
- Decided
- Feb 20, 2026
- Review
- 267 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 8 generations to DEN070003 (2008). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 8 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 7 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 6 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 5 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 4 generations backK143531 Rapid Therapy SystemMagstim Company Limited · 2015 · Recalled
- 3 generations backK160309 Neurosoft TMSTeleemg, LLC · 2016
- 2 generations backK173441 Neurosoft TMS (also CloudTMS)Teleemg, LLC · 2017
- 1 generation backK220625 ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemRemed Co., Ltd. · 2022
- This deviceK251653 SPRY TMS Therapy System (0550)Soterix Medical, Inc. · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −8 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −7 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −6 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −5 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −4 | K143531 | Rapid Therapy System | Magstim Company Limited | 2015 | 3 |
| −3 | K160309 | Neurosoft TMS | Teleemg, LLC | 2016 | — |
| −2 | K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | 2017 | — |
| −1 | K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System | Remed Co., Ltd. | 2022 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy SystemSummary page 5…ct Code: Fax: OBP Device Class: Class II Regulation Number: 882.5805 Classification Panel:Neurology III. PREDICATE DEVICE ALTMS Magnetic Stimulation Therapy System, K220625 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The SPRY TMS Therapy System is a medical device deve… | 2022 |
What descends from it?
No later submission names this one as a predicate yet.
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 18 years and passes through 5 companies; a new generation was cleared every 1.6 years on median.
- 2 of the 12 ancestors have a recall of any class.
How does its category compare?
All OBP devicesOBP Transcranial Magnetic Stimulator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, 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 SPRY 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/K251653 · printed Nov 4, 2026
Cite this page
510(k) Report. “K251653: SPRY TMS Therapy System (0550).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K251653
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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