Somatics, Inc.: FDA filings under this applicant name
FDA lists 7 510(k) clearances under the applicant name “Somatics, Inc.” (first 1984, latest 1999), across 4 product codes in 2 review panels. Median 510(k) review time under this name: 82 days. 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 | 0 | — |
| 2014 | 0 | — |
| 2015 | 0 | — |
| 2016 | 0 | — |
| 2017 | 0 | — |
| 2018 | 0 | — |
| 2019 | 0 | — |
| 2020 | 0 | — |
| 2021 | 0 | — |
| 2022 | 0 | — |
| 2023 | 0 | — |
| 2024 | 0 | — |
| 2025 | 0 | — |
| 2026 | 0 | — |
Top product codes
| Product code | Device | Submissions | 510(k) clearances |
|---|---|---|---|
| GXY | Electrode, Cutaneous | 2 | 2 |
| JXL | Block, Bite | 2 | 2 |
| QGH | Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder | 2 | 2 |
| DSF | Recorder, Paper Chart | 1 | 1 |
Review panels
- Neurology (6)
- Cardiovascular (1)
Most recent Somatics, Inc. 510(k) clearances
| 510(k) | Device | Product code | Decision date | Review days |
|---|---|---|---|---|
| K992269 | VENTIL-A ORAL PROTECTOR | JXL | 1999-10-25 | 111 |
| K945120 | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | QGH | 1995-10-26 | 372 |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | DSF | 1989-06-02 | 109 |
| K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | GXY | 1989-03-14 | 29 |
| K882809 | THYMAPAD | GXY | 1988-09-27 | 82 |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | JXL | 1986-11-03 | 7 |
| K843923 | THYMATRON | QGH | 1984-12-03 | 59 |
Recalls
openFDA lists no recalls under a recalling firm named Somatics, 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.
Frequently asked questions
How many FDA 510(k) clearances are listed under Somatics, Inc.?
FDA lists 7 510(k) clearances under the applicant name “Somatics, Inc.” (first 1984, latest 1999), across 4 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 Somatics, Inc.?
The median time from FDA receipt to decision across 510(k)s cleared under the name Somatics, Inc. is 82 days.
Which FDA product codes appear under Somatics, Inc.?
The most frequent FDA product codes under this applicant name are GXY (Electrode, Cutaneous, 2); JXL (Block, Bite, 2); QGH (Electroconvulsive Therapy Device For Catatonia, Major Depressive Disorder, And Bipolar Disorder, 2).
Next steps
- See all 7 Somatics, Inc. clearances with predicates and recalls
- Run predicate analysis for product code GXY, Somatics, 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 (spelling variants such as punctuation and legal suffixes combined); filings under other names are not included. Review days run from FDA receipt to decision. Not regulatory advice. Report an error in this data.