510(k) · Cleared
ClearedAmpa One System (AMPA-001)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Neuromodulatory Devices & Applications · OBP Transcranial Magnetic Stimulator
Cleared on Jun 27, 2025 as substantially equivalent to K243319 (Neuromodulatory Devices & Applications, 2025) after a 70-day review. Its family tree reaches back 9 generations to 2008.
- Decided
- Jun 27, 2025
- Review
- 70 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 9 generations to DEN070003 (2008). 18 ancestors in all. No later device cites it as a predicate yet.
- 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 backK243319 Ampa One System (AMPA-001)Neuromodulatory Devices & Applications · 2025
- This deviceK251210 Ampa One System (AMPA-001)Neuromodulatory Devices & Applications · 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 backK243319 Ampa One System (AMPA-001)Neuromodulatory Devices & Applications · 2025
- This deviceK251210 Ampa One System (AMPA-001)Neuromodulatory Devices & Applications · 2025
View 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 | K243319 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025 | — |
| 0 (this device) | K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 3 | 0 |
| 2018 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 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 |
|---|---|---|---|
| * | K243319 | Ampa One System (AMPA-001)Summary page 5…n system Transcranial Magnetic Stimulator 882.5805 OBP Predicate Devices Predicate Trade Name (Primary Predicate is listed first) 21 CFR 807.92(a)(3) Product Code K243319 Ampa One System OBP Device Description Summary 21 CFR 807.92(a)(4) previously cleared design. current episode. Please note… | 2025 |
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 17 years and passes through 5 companies; a new generation was cleared every 1.1 years on median.
- 2 of the 18 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. 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 Ampa One System is intended for 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/K251210 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251210: Ampa One System (AMPA-001).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251210
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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