510(k) · Cleared
ClearedBTL-995-rTMS
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
BTL Industries, Inc. · OBP Transcranial Magnetic Stimulator
Cleared on Mar 4, 2022 as substantially equivalent to K150641 (Tonica Elektronik A/S, 2015) after a 189-day review. Its family tree reaches back 5 generations to 2008. 1 later device descends from it.
- Decided
- Mar 4, 2022
- Review
- 189 days
- Class
- Class II
- Product code
- OBP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to DEN070003 (2008). 1 later device descends from it, 1 citing it directly.
- Root · 5 generations backDEN070003 Neurostar TMS SystemNeuronetics · 2008
- 4 generations backK083538 Neurostar TMS Therapy System, Model 1.1Neuronetics · 2008 · Recalled
- 3 generations backK130233 Neurostar TMS Therapy SystemNeuronetics · 2013
- 2 generations backK133408 Neurostar TMS Therapy SystemNeuronetics · 2014
- 1 generation backK150641 MagVita TMS Therapy SystemTonica Elektronik A/S · 2015
- This deviceK212723 BTL-995-rTMSBTL Industries, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK260691 BTL-699BTL Industries, Inc. · 2026
Most influential descendants
Showing 1 of 1 · See all- K260691BTL-699BTL Industries, Inc. · 2026 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | DEN070003 | Neurostar TMS System | Neuronetics | 2008 | — |
| −4 | K083538 | Neurostar TMS Therapy System, Model 1.1 | Neuronetics | 2008 | 1 |
| −3 | K130233 | Neurostar TMS Therapy System | Neuronetics | 2013 | — |
| −2 | K133408 | Neurostar TMS Therapy System | Neuronetics | 2014 | — |
| −1 | K150641 | MagVita TMS Therapy System | Tonica Elektronik A/S | 2015 | — |
| 0 (this device) | K212723 | BTL-995-rTMS | BTL Industries, Inc. | 2022 | — |
| +1 | K260691 | BTL-699 | BTL Industries, Inc. | 2026 | — |
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? (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 |
|---|---|---|---|
| * | K150641 | MagVita TMS Therapy SystemSummary page 5…t to the current product that is already cleared for distribution in the USA under the following 510(k) Premarket Notification number: ● MagVita TMS Therapy System (K150641) Product Description The BTL-995-rTMS is a non-invasive therapeutic device that produces and delivers magnetic field to induce… | 2015 |
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 |
|---|---|---|---|
| K260691 | BTL-699 | 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 3 companies; a new generation was cleared every 1.3 years on median.
- 1 of the 5 ancestors has a recall of any class.
- Of its descendants, K260691 (BTL Industries, Inc., 2026) has gone furthest, with 0 descendants of its own.
- 10 other devices also cite its predicate K150641.
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?
BTL-995-rTMS is indicated to be used 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 read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K212723 · printed Nov 4, 2026
Cite this page
510(k) Report. “K212723: BTL-995-rTMS.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K212723
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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