# K251653: SPRY TMS Therapy System (0550)

- Pathway: 510(k) (Traditional)
- Applicant: Soterix Medical, Inc.
- Decided: Feb 20, 2026 after 267 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: 8 generations back to DEN070003 (2008). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K220625: ALTMS Magnetic Stimulation Therapy System, Blossom TMS Therapy System, Remed Co., Ltd. (2022) Summary page 5.

## Indications for use
The SPRY TMS Therapy System is indicated 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/K251653
Methodology: https://510kreport.com/methodology