Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
JTL · Predicate Candidate Screening
12 FDA 510(k) clearances under this product code; the 50 most recent screened below.
31 daysmedian FDA review time
90 days90th percentile
12clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K950706 | DRYSLIDE COAGULASE | Difco Laboratories, Inc. | 1995-05-16 | 90 | 0 |
| K883333 | RABBIT PLASMA FIBRINOGEN (RPF) SUPPLEMENT | Immuno-Mycologics, Inc. | 1988-08-25 | 16 | 0 |
| K870945 | RABBIT PLASMA FIBRINOGEN SUPPLEMENT SR 122 | Oxoid U.S.A., Inc. | 1987-06-10 | 93 | 0 |
| K861312 | LYFO-KWIK (TM) COAGULASE PLASMA | Micro-Bio-Logics | 1986-04-18 | 10 | 0 |
| K840553 | HEMASTAPH | Remel Co. | 1984-04-13 | 65 | 0 |
| K833988 | API STAPHASE III | Analytical Products, Inc. | 1983-12-22 | 34 | 0 |
| K833858 | COAGULASE PLASMA, HORSE & RABBIT EDTA | Otisville Biotech, Inc. | 1983-12-08 | 31 | 0 |
| K822988 | COAGULASE PLASMA-CITRATED & EDTA | American Scientific Products | 1982-11-05 | 24 | 0 |
| K820177 | COAGULASE PLASMA | Quadroma, Inc. | 1982-02-05 | 14 | 0 |
| K812602 | RABBIT COAGULASE PLASMA | Dutchland Laboratories, Inc. | 1981-09-29 | 14 | 0 |
| K811982 | STAPHASE* | Analytical Products, Inc. | 1981-07-28 | 15 | 0 |
| K792235 | COAGULASE PLASMA | Remel Co. | 1979-12-07 | 31 | 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