Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neuronetics — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
502 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | Neuronetics | 2023-12-13 | 30 | 0 |
| K231350 | OCD MT Cap (85-00397-000) | Neuronetics | 2023-06-08 | 30 | 0 |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | Neuronetics | 2023-04-04 | 90 | 0 |
| K133408 | NEUROSTAR TMS THERAPY SYSTEM | Neuronetics | 2014-03-28 | 142 | 0 |
| K130233 | NEUROSTAR TMS THERAPY SYSTEM | Neuronetics | 2013-04-30 | 90 | 0 |
| K083538 | NEUROSTAR TMS THERAPY SYSTEM, MODEL 1.1 | Neuronetics | 2008-12-16 | 18 | 1 |
| DEN070003 | NEUROSTAR TMS SYSTEM | Neuronetics | 2008-10-07 | 502 | 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