Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
QCI — Predicate Candidate Screening
9 FDA 510(k) clearances under this product code; the 50 most recent screened below.
286 daysmedian FDA review time
329 days90th percentile
9clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K243459 | Ultimate rTMS for OCD (M-series) | Brain Ultimate, Inc. | 2025-04-17 | 160 | 0 |
| K230657 | BTL-99-OC | BTL Industries, Inc. | 2024-02-01 | 329 | 0 |
| K233742 | CloudTMS Edge for OCD | Teleemg, LLC | 2023-12-22 | 30 | 0 |
| K231350 | OCD MT Cap (85-00397-000) | Neuronetics | 2023-06-08 | 30 | 0 |
| K221129 | CloudTMS for OCD | Teleemg, LLC | 2023-03-10 | 326 | 0 |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, | Neuronetics, Inc. | 2022-05-06 | 289 | 0 |
| K193006 | MagVenture TMS Therapy – for treatment of OCD, MagVenture TM | Tonica Elektronik A/S | 2020-08-09 | 286 | 0 |
| K183303 | Brainsway Deep TMS System | Brainsway , Ltd. | 2019-03-08 | 101 | 0 |
| DEN170078 | Brainsway Deep Transcranial Magnetic Stimulation (DTMS) Syst | Brainways , Ltd. | 2018-08-17 | 322 | 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