SPRY TMS Therapy System (0550)
FDA 510(k) K251653 · Soterix Medical, Inc.
510(k) numberK251653
Submission
- Device name
- SPRY TMS Therapy System (0550)
- Applicant
- Soterix Medical, Inc.
Woodbridge, NJ, US - Received
- May 29, 2025
- Decision date
- February 20, 2026
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- OBP – Transcranial Magnetic Stimulator
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 882.5805
- Specialty
- Neurology
A transcranial magnetic stimulator is a device that delivers brief duration, rapidly alternating, or pulsed, magnetic fields to induce electrical currents that are directed at spatially discrete regions of the cerebral cortex for the treatment of major depressive disorder.
Other 510(k)s with product code OBP
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K260396 | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A)OBP · Traditional | Fidelity BioPharma Co. | 09/06/2026SE |
| K260691 | BTL-699OBP · Traditional | BTL Industries, Inc. | 08/23/2026SE |
| K261228 | QuickVision Ultimate rTMSOBP · Traditional | Brain Ultimate, Inc. | 08/14/2026SE |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy SystemOBP · Traditional | Mag & More GmbH | 05/22/2026SE |
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy SystemOBP · Traditional | Tonica Elektronik A/S | 05/22/2026SE |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6)OBP · Traditional | Nexstim Oyj | 03/20/2026SE |
| K251391 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 11/07/2025SE |
| K250689 | CloudTMS EdgeOBP · Traditional | Teleemg, LLC | 09/14/2025SE |
| K251449 | BrainsWay Deep TMS SystemOBP · Traditional | Brainsway , Ltd. | 09/13/2025SE |
More from Brainsway , Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K233751 | Milieve (YPS-301BD)PCC · Traditional | 06/03/2024SE |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S)GWF · Traditional | 03/25/2024SE |
| K192823 | Mega-TmsGWF · Traditional | 08/13/2021SE |
| K191422 | Neural NavigatorHAW · Traditional | 04/06/2020SE |
| K170291 | IontoDCEGJ · Traditional | 05/01/2017SE |
Questions and answers
When was SPRY TMS Therapy System (0550) cleared by the FDA?
SPRY TMS Therapy System (0550) (K251653) received a 510(k) decision of Substantially Equivalent on February 20, 2026, 267 days after the submission was received.
What is the product code of K251653?
The FDA product code is OBP – Transcranial Magnetic Stimulator, a Class II (moderate risk) device regulated under 21 CFR 882.5805.