Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Affinity Biologicals, Inc. — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
180 daysmedian FDA review time
409 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K150144 | VisuCon-F Low Fibrinogen Control Plasma | Affinity Biologicals, Inc. | 2016-03-06 | 409 | 0 |
| K110432 | VISUCON-F FROZEN COAG SCREEN N, VISUCON-F FROZEN COAG SCREEN | Affinity Biologicals, Inc. | 2011-10-20 | 247 | 0 |
| K091284 | VISUCAL-F FROZEN CALIBRATOR PLASMA AND VISUCON-F FROZEN NORM | Affinity Biologicals, Inc. | 2009-10-28 | 180 | 0 |
| K052825 | VISULIZE FACTOR VIII ANTIGEN KIT, MODEL FVIII-AG | Affinity Biologicals, Inc. | 2006-01-20 | 107 | 0 |
| K051054 | VISULIZE FACTOR IX ANTIGEN KIT | Affinity Biologicals, Inc. | 2005-06-29 | 64 | 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