Neuronetics, Inc.: FDA filings under this applicant name
FDA lists 14 510(k) clearances under the applicant name “Neuronetics, Inc.” (first 2008, latest 2024), plus 1 De Novo decision, across 2 product codes in 1 review panel. Median 510(k) review time under this name: 90 days. Since 2017 the median was 90 days, against 141 days for all cleared 510(k)s in the same product codes. Related companies, subsidiaries and acquired businesses that file under other applicant names are counted on their own pages, not here.
510(k) clearances per year
| Year | Clearances | Median review days |
|---|---|---|
| 2012 | 0 | — |
| 2013 | 1 | 90 |
| 2014 | 1 | 142 |
| 2015 | 0 | — |
| 2016 | 2 | 94 |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 204 |
| 2021 | 1 | 32 |
| 2022 | 3 | 178 |
| 2023 | 3 | 30 |
| 2024 | 1 | 266 |
| 2025 | 0 | — |
| 2026 | 0 | — |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Neuronetics, Inc. took a median 90 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 141 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| OBP | Transcranial Magnetic Stimulator | 13 | 12 |
| QCI | Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder | 2 | 2 |
Review panels
- Neurology (15)
Most recent Neuronetics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K231926 | NeuroStar Advanced Therapy System (All previously cleared models) | OBP | 2024-03-22 | 266 |
| K233621 | NeuroStar Advanced Therapy System (Version 3.8) | OBP | 2023-12-13 | 30 |
| K231350 | OCD MT Cap (85-00397-000) | QCI | 2023-06-08 | 30 |
| K230029 | NeuroStar Advanced Therapy System (Version 3.7) | OBP | 2023-04-04 | 90 |
| K222230 | NeuroStar, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar Advanced Therapy System for Mental Health | OBP | 2022-08-24 | 30 |
| K220127 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | OBP | 2022-07-15 | 178 |
| K212289 | NeuroStar Advanced Therapy for adjunctive treatment of OCD, NeuroStar Advanced Therapy System, NeuroStar TMS Therapy System, NeuroStar Advanced Therapy for Mental Health, NeuroStar | QCI | 2022-05-06 | 289 |
| K213543 | NeuroStar TMS Therapy System, NeuroStar Advanced Therapy System, NeuroStar, NeuroStar Advanced Therapy for Mental Health | OBP | 2021-12-10 | 32 |
| K201158 | NeuroStar Advanced Therapy | OBP | 2020-11-20 | 204 |
| K161519 | NeuroStar TMS Therapy System | OBP | 2016-09-11 | 101 |
4 earlier clearances. See the full list in Caduvo.
PMA and De Novo decisions
| Number | Pathway | Device | Decision date |
|---|---|---|---|
| DEN070003 | De Novo | Transcranial Magnetic Stimulator | 2008-10-07 |
Recalls
1 product recalls in 1 recall events; 0 initiated in the last five years. Most recent: 2009-03-16.
Recalling firms are matched to this applicant name by name only (same normalization), so related entities that recall under another name are not counted. A recall count says nothing about how safe one company's devices are compared with another's.
SEC filings
Neuronetics, Inc. (STIM): EDGAR filings, CIK 1227636. An SEC registrant with the same name, matched by name only.
Frequently asked questions
How many FDA 510(k) clearances are listed under Neuronetics, Inc.?
FDA lists 14 510(k) clearances under the applicant name “Neuronetics, Inc.” (first 2008, latest 2024), plus 1 De Novo decision, across 2 product codes in 1 review panel. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Neuronetics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Neuronetics, Inc. is 90 days. Since 2017: 90 days, versus 141 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Neuronetics, Inc.?
The most frequent FDA product codes under this applicant name are OBP (Transcranial Magnetic Stimulator, 13); QCI (Transcranial Magnetic Stimulation System For Obsessive-Compulsive Disorder, 2).
Next steps
- See all 14 Neuronetics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code OBP, Neuronetics, Inc.'s most frequent
Data from openFDA (510(k), PMA, De Novo, device recalls), ClinicalTrials.gov and SEC company tickers. Each page covers one FDA applicant name, with punctuation and legal suffixes removed; filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.