Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Corometrics Medical Systems, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
90 daysmedian FDA review time
134 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K982651 | COROMETRICS MODEL 5700 AND 2264 WATERTIGHT TRANSDUCER | Corometrics Medical Systems, Inc. | 1998-12-11 | 134 | 0 |
| K905000 | ALOKA UST-964P-5 ENDOVAGINAL TRANSDUCER | Corometrics Medical Systems, Inc. | 1991-01-31 | 85 | 0 |
| K903623 | MODEL600 UTERINE ACTIVITY MONITOR | Corometrics Medical Systems, Inc. | 1990-11-07 | 90 | 0 |
| K891997 | CATALOG #2270AAX, 2270DAX BELTLESS TOCOTRANSDUCER | Corometrics Medical Systems, Inc. | 1989-06-08 | 72 | 0 |
| K880900 | SSD-620 LINEAR/CONVEX ARRAY SECTOR SCANNER | Corometrics Medical Systems, Inc. | 1988-06-01 | 91 | 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