Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Somatics, Inc. — Predicate Candidate Screening
7 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
82 daysmedian FDA review time
372 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K992269 | VENTIL-A ORAL PROTECTOR | Somatics, Inc. | 1999-10-25 | 111 | 0 |
| K945120 | THYMATRON 2000 ELECTROCONVULSIVE SYSTEM | Somatics, Inc. | 1995-10-26 | 372 | 0 |
| K890711 | DUAL GRAPH (TM) RECORDER-MONITOR | Somatics, Inc. | 1989-06-02 | 109 | 0 |
| K890710 | DISPOSABLE EEG/EKG ELECTRODE, CAT. #EEDS | Somatics, Inc. | 1989-03-14 | 29 | 0 |
| K882809 | THYMAPAD | Somatics, Inc. | 1988-09-27 | 82 | 0 |
| K864181 | SOMATICS MOUTH GUARD (BITE BLOCK) | Somatics, Inc. | 1986-11-03 | 7 | 0 |
| K843923 | THYMATRON | Somatics, Inc. | 1984-12-03 | 59 | 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