Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JCA · Predicate Candidate Screening
7 FDA 510(k) clearances under this product code; the 50 most recent screened below.
72 daysmedian FDA review time
113 days90th percentile
7clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K911745 | SIMPLATE PEDIATRIC | Organon Teknika Corp. | 1991-08-09 | 113 | 0 |
| K911996 | SURGICUTT-BLEEDING TIME DEVICE, MODIFICATION | International Technidyne Corp. | 1991-07-17 | 86 | 0 |
| K871318 | Q.I.C. BLEEDING TIME DEVICE | Helena Laboratories | 1987-06-10 | 68 | 0 |
| K850542 | SURGICUTT - BLEEDING TIME DEVICE | International Technidyne Corp. | 1985-03-01 | 18 | 0 |
| K830645 | BLEEDING TIME DEVICE DISPOSABLE | American Dade | 1983-03-17 | 16 | 0 |
| K801815 | AUTOLET | Ulster Scientific, Inc. | 1980-10-10 | 72 | 0 |
| K761250 | SIMPLATE | General Diagnostics | 1977-03-01 | 78 | 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