# K260691: BTL-699

- Pathway: 510(k) (Traditional)
- Applicant: BTL Industries, Inc.
- Decided: Aug 23, 2026 after 173 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: 13 generations back to DEN070003 (2008). 30 ancestors in all.
No later device cites it as a predicate yet.
0 of 31 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K251119: MagVenture TMS Therapy System, Tonica Elektronik A/S (2025) Summary page 6.
- K212723: BTL-995-rTMS, BTL Industries, Inc. (2022) Summary page 6.
- K230657: BTL-99-OC, BTL Industries, Inc. (2024) Summary page 6.
- K233621: NeuroStar Advanced Therapy System (Version 3.8), Neuronetics (2023) Summary page 6.
- K251125: MagVenture TMS Therapy System, Tonica Elektronik A/S (2025) Summary page 6.

## Indications for use
The BTL-699 is indicated for the treatment of depressive episodes and for decreasing anxiety symptoms for those who may exhibit comorbid anxiety symptoms in adult patients suffering from Major Depressive Disorder (MDD) and who have failed to achieve satisfactory improvement from prior antidepressant medication in the current episode. The BTL-699 is intended to be used as an adjunct for the treatment of adult patients suffering from Obsessive-Compulsive Disorder (OCD). The BTL-699 is indicated as an adjunct for the treatment of Major Depressive Disorder in adolescent patients (age 15-21).

Source page: https://510kreport.com/device/K260691
Methodology: https://510kreport.com/methodology