Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neuronetics, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
178 daysmedian FDA review time
289 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K231926 | NeuroStar Advanced Therapy System (All previously cleared mo | Neuronetics, Inc. | 2024-03-22 | 266 | 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 |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, | Neuronetics, Inc. | 2022-05-06 | 289 | 0 |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy Sys | Neuronetics, Inc. | 2021-12-10 | 32 | 0 |
| K201158 | NeuroStar Advanced Therapy | Neuronetics, Inc. | 2020-11-20 | 204 | 0 |
| K161519 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016-09-11 | 101 | 0 |
| K160703 | NeuroStar TMS Therapy System | Neuronetics, Inc. | 2016-06-10 | 88 | 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