Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Cmc Sense-It, 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) |
|---|---|---|---|---|---|
| K970603 | D SERIES ELECTRODE | Cmc Sense-It, Inc. | 1997-04-01 | 42 | 0 |
| K963159 | CONDUCTIVE HYDROGEL POLYMER BASED ON U & C SERIES ELECTRODES | Cmc Sense-It, Inc. | 1996-12-11 | 119 | 0 |
| K955815 | G3000 OR AG2000; DISPOSABLE RESTING ELECTRODE | Cmc Sense-It, Inc. | 1996-07-23 | 210 | 0 |
| K955800 | SI2000 (SENSE-IT TRADEMARK) OR G2000; DISPOSABLE RESTING ELE | Cmc Sense-It, Inc. | 1996-05-17 | 147 | 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