510(k) · Cleared
ClearedKCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Fidelity BioPharma Co. · OBP Transcranial Magnetic Stimulator
Cleared on Sep 6, 2026 as substantially equivalent to K230735 (Brain Ultimate, Inc., 2023) after a 212-day review. Its family tree reaches back 7 generations to 2008.
- Decided
- Sep 6, 2026
- Review
- 212 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to DEN070003 (2008). 9 ancestors in all. No later device cites it as a predicate yet.
- 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 backK150641 MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
- 2 generations backK171481 MagVita TMS Therapy SystemTonica Elektronik A/S · 2017
- 1 generation backK230735 Ultimate rTMS; Yingchi rTMSBrain Ultimate, Inc. · 2023
- This deviceK260396 KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim…Fidelity BioPharma Co. · 2026
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 | K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 | — |
| −2 | K171481 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2017 | — |
| −1 | K230735 | Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. | 2023 | — |
| 0 (this device) | K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100… | Fidelity BioPharma Co. | 2026 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 1 | 0 |
| 2016 | 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 |
|---|---|---|---|
| * | K230735 | Ultimate rTMS; Yingchi rTMSSummary page 5…OBP 4. Predicate Device Information Primary predicate: Sponsor: Brain Ultimate, Inc. Trade Name: Ultimate rTMS; Yingchi rTMS Regulation: 21 CFR 882.5805 510(k) Number: K230735 Regulation Name: Repetitive transcranial magnetic stimulation system Regulatory Class: Class II Product Code: OBP Reference devi… | 2023 |
| † | K173441 | Neurosoft TMS (also CloudTMS) | 2017 |
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 4 companies; a new generation was cleared every 1.9 years on median.
- 2 of the 9 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 KCS rTMS Therapy System (Transcranial Magnetic Stimulator) is indicated for the treatment of Major Depressive Disorder in adult patients who have failed to receive satisfactory improvement from prior antidepressant medication in the current episode.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K260396 · printed Nov 6, 2026
Cite this page
510(k) Report. “K260396: KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K260396
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026