Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
MIF · Predicate Candidate Screening
6 FDA 510(k) clearances under this product code; the 50 most recent screened below.
135 daysmedian FDA review time
212 days90th percentile
6clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K042687 | ENZYGNOST F+2 (MONOCLONAL) TEST KIT | Dade Behring, Inc. | 2004-12-10 | 72 | 0 |
| K964934 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | 1997-03-18 | 99 | 0 |
| K962176 | TPP | Panbio, Inc. | 1996-10-18 | 135 | 0 |
| K922934 | ENZYGNOST F 1+2 | Behring Diagnostics, Inc. | 1992-11-16 | 151 | 0 |
| K920895 | DADE(R) PROTHROMBIN FRAGMENT F1.2 ELISA | Baxter Diagnostics, Inc. | 1992-06-04 | 99 | 0 |
| K911434 | THROMBONOSTIKA F1.2 | Organon Teknika Corp. | 1991-10-31 | 212 | 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