Predicate Research Report · generated 2026-08-21 · Print / save as PDF · Save to account
OBP — Predicate Candidate Screening
66 FDA 510(k) clearances under this product code; the 50 most recent screened below.
141 daysmedian FDA review time
268 days90th percentile
66clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K260189 | MagVenture Accelerated TMS (aTMS) Therapy System | Tonica Elektronik A/S | 2026-05-22 | 120 | 0 |
| K260560 | Apollo TMS Therapy System;Apollo light TMS Therapy System | Mag & More GmbH | 2026-05-22 | 92 | 0 |
| K253098 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 | 178 | 0 |
| K252358 | Nexstim Navigated Brain Stimulation (NBS) 6 System (NBS6) | Nexstim Oyj | 2026-03-20 | 234 | 0 |
| K251653 | SPRY TMS Therapy System (0550) | Soterix Medical, Inc. | 2026-02-20 | 267 | 0 |
| K251391 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-11-07 | 186 | 0 |
| K250689 | CloudTMS Edge | Teleemg, LLC | 2025-09-14 | 192 | 0 |
| K251449 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2025-09-13 | 127 | 0 |
| K243700 | Apollo TMS Therapy System | Mag & More GmbH | 2025-09-04 | 279 | 0 |
| K243539 | Apollo TMS Therapy System | Mag & More GmbH | 2025-08-18 | 276 | 0 |
| K251125 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-11 | 122 | 0 |
| K251119 | MagVenture TMS Therapy System | Tonica Elektronik A/S | 2025-08-08 | 119 | 0 |
| K252032 | T65 (9016E061-) | Tonica Elektronik A/S | 2025-07-30 | 30 | 0 |
| K251210 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025-06-27 | 70 | 0 |
| K243460 | Ultimate rTMS | Brain Ultimate, Inc. | 2025-04-17 | 160 | 0 |
| K243869 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horiz | The Magstim Company Limited | 2025-03-17 | 90 | 0 |
| K243319 | Ampa One System (AMPA-001) | Neuromodulatory Devices & Applications | 2025-02-13 | 113 | 0 |
| K241518 | Horizon® 3.0 TMS Therapy System (Horizon 3.0 Inspire); Horiz | The Magstim Company Limited | 2024-08-30 | 93 | 0 |
| K222196 | Deep TMS System | Brainsway , Ltd. | 2024-05-31 | 679 | 0 |
| K232639 | Apollo TMS Therapy System | Mag & More GmbH | 2024-05-24 | 268 | 0 |
| K231926 | NeuroStar Advanced Therapy System (All previously cleared mo | Neuronetics, Inc. | 2024-03-22 | 266 | 0 |
| K233631 | ZapStim Controller Application (Z1023) | Revital Lab, Inc. | 2024-02-09 | 88 | 0 |
| K232688 | NQ TMS for MDD (NQv1-MU-01) | Neuroqore, Inc. | 2023-12-29 | 119 | 0 |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics | 2023-12-13 | 30 | 0 |
| K232235 | Magstim®Horizon® 3.0 TMS Therapy System; Horizon® 3.0 System | The Magstim Company , Ltd. | 2023-10-25 | 90 | 0 |
| K230735 | Ultimate rTMS; Yingchi rTMS | Brain Ultimate, Inc. | 2023-09-13 | 181 | 0 |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023-04-04 | 90 | 0 |
| K223154 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, | Magstim Company, Ltd. | 2023-03-16 | 161 | 0 |
| K222171 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, | Magstim Company, Ltd. | 2023-01-13 | 176 | 0 |
| K220177 | Magnus Neuromodulation System (MNS) with SAINT Technology, M | Magnus Medical, Inc. | 2022-09-01 | 223 | 0 |
| K220819 | BrainsWay Deep TMS System | Brainsway , Ltd. | 2022-08-26 | 158 | 0 |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced | Neuronetics, Inc. | 2022-08-24 | 30 | 0 |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy Sys | Neuronetics, Inc. | 2022-07-15 | 178 | 0 |
| K220625 | ALTMS Magnetic Stimulation Therapy System, Blossom TMS Thera | Remed Co., Ltd. | 2022-04-06 | 34 | 0 |
| K212723 | BTL-995-rTMS | BTL Industries, Inc. | 2022-03-04 | 189 | 0 |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy Sys | Neuronetics, Inc. | 2021-12-10 | 32 | 0 |
| K202537 | ALTMS Magnetic Stimulation Therapy System | Remed Co., Ltd. | 2021-11-26 | 451 | 0 |
| K211389 | Magstim Horizon 3.0 TMS Therapy System, Horizon 3.0 System, | Magstim Company, Ltd. | 2021-09-14 | 132 | 0 |
| K210201 | Deep Transcranial Magnetic Stimulation (DTMS) System | Brainsway , Ltd. | 2021-08-17 | 204 | 0 |
| K203735 | Brainsway Deep TMS System | Brainsway , Ltd. | 2021-04-23 | 123 | 0 |
| K201158 | NeuroStar Advanced Therapy | Neuronetics, Inc. | 2020-11-20 | 204 | 0 |
| K183376 | HORIZON TMS Therapy System with Navigation | Magstim Company, Ltd. | 2019-04-03 | 118 | 0 |
| K182700 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2019-03-22 | 176 | 0 |
| K182853 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2019-03-15 | 156 | 0 |
| K173620 | Mag Vita TMS Therapy System w/Theta Burst Stimulation | Tonica Elektronik A/S | 2018-08-14 | 265 | 0 |
| K180907 | HORIZON TMS Therapy System | Magstim Company, Ltd. | 2018-08-03 | 119 | 0 |
| K180313 | Apollo TMS Therapy System | Mag & More GmbH | 2018-05-04 | 88 | 0 |
| K173540 | Brainsway Deep (DTMS) System | Brainsway , Ltd. | 2018-05-03 | 169 | 0 |
| K173441 | Neurosoft TMS (also CloudTMS) | Teleemg, LLC | 2017-12-13 | 37 | 0 |
| K171902 | Nexstim Navigated Brain Therapy (NBT) System 2 | Nexstim Plc | 2017-11-10 | 137 | 0 |
Methodology
Recall counts reflect FDA recall records explicitly referencing each K-number; FDA links recalls to K-numbers inconsistently, so 0 means "none found in FDA records," not "never recalled." Data: FDA openFDA, refreshed weekly. Verify decisions of consequence against the primary source. Full candidate set and CSV export: atlasbyauro.com.
Prepared with Atlas
Predicate research, review-time statistics and recall monitoring for 510(k) teams — atlasbyauro.com/fda