Soterix Medical, Inc.: FDA filings under this applicant name
FDA lists 6 510(k) clearances under the applicant name “Soterix Medical, Inc.” (first 2017, latest 2026), across 5 product codes in 2 review panels. Median 510(k) review time under this name: 230 days. Since 2017 the median was 230 days, against 139 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 |
|---|---|---|
| 2017 | 1 | 90 |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 1 | 313 |
| 2021 | 1 | 681 |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 2 | 144 |
| 2025 | 0 | — |
| 2026 | 1 | 267 |
Review time against the same product codes
Since 2017, 510(k)s cleared under the name Soterix Medical, Inc. took a median 230 days from FDA receipt to decision. All cleared 510(k)s in the same product codes over the same years took a median 139 days.
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GWF | Stimulator, Electrical, Evoked Response | 2 | 2 |
| EGJ | Device, Iontophoresis, Other Uses | 1 | 1 |
| HAW | Neurological Stereotaxic Instrument | 1 | 1 |
| OBP | Transcranial Magnetic Stimulator | 1 | 1 |
| PCC | Stimulator, Nerve, Electrical, Transcutaneous, For Migraine | 1 | 1 |
Review panels
- Neurology (5)
- Physical Medicine (1)
Most recent Soterix Medical, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K251653 | SPRY TMS Therapy System (0550) | OBP | 2026-02-20 | 267 |
| K233751 | Milieve (YPS-301BD) | PCC | 2024-06-03 | 194 |
| K234080 | MEGA-IOM system with Neuro-IOM.NET software (32/B - 32/S - 16/S) | GWF | 2024-03-25 | 94 |
| K192823 | MEGA-TMS | GWF | 2021-08-13 | 681 |
| K191422 | Neural Navigator | HAW | 2020-04-06 | 313 |
| K170291 | IontoDC | EGJ | 2017-05-01 | 90 |
Recalls
openFDA lists no recalls under a recalling firm named Soterix Medical, Inc..
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.
Device clinical trials
An industry sponsor named Soterix Medical, Inc. is the lead sponsor of 9 device studies on ClinicalTrials.gov (1 active or recruiting). Most recent:
- NCT07042217: Transcranial Direct Current Stimulation for Depression (Recruiting, started 2025-07-01)
- NCT05598931: Development of Neuro-Navigated Transcranial Magnetic Stimulation (TMS) Using MRI (Completed, started 2021-07-01)
- NCT04956081: Virtual Neuro-Navigation System for Personalized Community Based TMS (Completed, started 2021-07-01)
- NCT04781127: Home-administered tDCS for Treatment of Depression (Completed, started 2021-02-10)
- NCT04994821: TDCS to Reduce Craving in Cocaine Addiction- Phase 2 Study (Completed, started 2020-09-28)
Frequently asked questions
How many FDA 510(k) clearances are listed under Soterix Medical, Inc.?
FDA lists 6 510(k) clearances under the applicant name “Soterix Medical, Inc.” (first 2017, latest 2026), across 5 product codes in 2 review panels. Filings under other applicant names, such as subsidiaries, are not included.
How long has FDA taken to clear 510(k)s filed by Soterix Medical, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Soterix Medical, Inc. is 230 days. Since 2017: 230 days, versus 139 days for all cleared 510(k)s in the same product codes.
Which FDA product codes appear under Soterix Medical, Inc.?
The most frequent FDA product codes under this applicant name are GWF (Stimulator, Electrical, Evoked Response, 2); EGJ (Device, Iontophoresis, Other Uses, 1); HAW (Neurological Stereotaxic Instrument, 1).
Next steps
- See all 6 Soterix Medical, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GWF, Soterix Medical, 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.