Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Somnitec, Inc. — Predicate Candidate Screening
4 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911989 | GOLD CUP EEG CUTANEOUS ELECTRODE W/LEAD AND EXT. | Somnitec, Inc. | 1991-07-30 | 85 | 0 |
| K912817 | SOMNIMIC (R) | Somnitec, Inc. | 1991-07-26 | 66 | 0 |
| K912234 | SOMNIPROBE(R) MODEL NUMBER 10093, MODIFICATION | Somnitec, Inc. | 1991-07-22 | 66 | 0 |
| K911990 | ECG FEMALE-TO-PIN SNAP ELECTRODE W/LEADS AND EXT. | Somnitec, Inc. | 1991-06-21 | 46 | 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