# K212723: BTL-995-rTMS

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Mar 4, 2022 after 189 days
- Product code: OBP (Transcranial Magnetic Stimulator)
- Device class: 2
- Regulation: 21 CFR 882.5805
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 5 generations back to DEN070003 (2008). 5 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K150641: MagVita TMS Therapy System, Tonica Elektronik A/S (2015) Summary page 5.

## Most influential descendants
- K260691: BTL-699 (2026), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K212723
Methodology: https://510kreport.com/methodology