FDA product code OBP: Transcranial Magnetic Stimulator
OBP is the FDA product code for transcranial magnetic stimulator. It is a Class II device, regulated under 21 CFR 882.5805 and reviewed by the Neurology panel. FDA has cleared 68 510(k) submissions under OBP, 38 in the last five years, from 21 different applicants. The average 510(k) review took 152 days (median 139); 200 days on average over the last three years. 1 De Novo request was granted under it. FDA has posted 5 recalls for OBP devices.
Definition
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.
Classification
| Field | Value |
|---|---|
| Device name | Transcranial Magnetic Stimulator |
| Device class | Class II |
| Regulation | 21 CFR 882.5805 |
| Review panel | NE — Neurology |
| Medical specialty | Neurology |
| Premarket route | 510(k) |
510(k) clearances per year for OBP
| Year | Clearances | Avg. review days |
|---|---|---|
| 2017 | 8 | 83 |
| 2018 | 4 | 160 |
| 2019 | 3 | 150 |
| 2020 | 1 | 204 |
| 2021 | 5 | 188 |
| 2022 | 6 | 135 |
| 2023 | 7 | 121 |
| 2024 | 5 | 279 |
| 2025 | 12 | 147 |
| 2026 | 8 | 175 |
Compare with all 510(k) review times · Search every OBP clearance
Top OBP applicants
| Applicant | Clearances | Latest |
|---|---|---|
| Tonica Elektronik A/S | 10 | 2026-05-22 |
| Brainsway , Ltd. | 8 | 2025-11-07 |
| Magstim Company, Ltd. | 8 | 2023-03-16 |
| Neuronetics, Inc. | 7 | 2024-03-22 |
| Mag & More GmbH | 5 | 2026-05-22 |
16 more applicants have OBP clearances. See the full list in Caduvo.
Most recent OBP clearances
| 510(k) | Applicant | Device | Decision date | Review days |
|---|---|---|---|---|
| K260396 | Fidelity BioPharma Co. | KCS rTMS Therapy System (Transcranial Magnetic Stimulator) (MetaStim 100, MetaStim 100A) | 2026-09-06 | 212 |
| K260691 | BTL Industries, Inc. | BTL-699 | 2026-08-23 | 173 |
| K261228 | Brain Ultimate, Inc. | QuickVision Ultimate rTMS | 2026-08-14 | 121 |
| K260560 | Mag & More GmbH | Apollo TMS Therapy System;Apollo light TMS Therapy System | 2026-05-22 | 92 |
| K260189 | Tonica Elektronik A/S | MagVenture Accelerated TMS (aTMS) Therapy System | 2026-05-22 | 120 |
Recalls for OBP devices
5 product recalls in 4 recall events; 0 initiated in the last five years and 1 still open. Most recent: 2020-03-23.
| Year | Recalls |
|---|---|
| 2017 | 1 |
| 2018 | 1 |
| 2020 | 2 |
Frequently asked questions
What is FDA product code OBP?
OBP is the FDA product code for transcranial magnetic stimulator. It is a Class II device, regulated under 21 CFR 882.5805 and reviewed by the Neurology panel.
What device class is OBP?
Class II, regulation 21 CFR 882.5805. Typical premarket route: 510(k).
How long does a 510(k) take for product code OBP?
Across 68 cleared submissions the average was 152 days from receipt to decision (median 139).
Which companies have the most OBP clearances?
Tonica Elektronik A/S (10); Brainsway , Ltd. (8); Magstim Company, Ltd. (8); Neuronetics, Inc. (7); Mag & More GmbH (5).
Have OBP devices been recalled?
Yes: 5 product recalls across 4 recall events; the most recent began 2020-03-23.
Next steps
- Run an FDA pathway report with predicate devices for product code OBP
- Run a recall and safety report across every OBP manufacturer
- Watch product code OBP for new clearances and recalls
Source: openFDA device classification, 510(k), PMA, De Novo and recall data (public domain). Review days run from FDA receipt to decision. Not regulatory advice.
All Neurology product codes · FDA product code lookup · 510(k) database search · 510(k) review times