Predicate Research Report · generated 2026-08-23 · Print / save as PDF · Save to account
George King Bio-Medical, Inc. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
340 daysmedian FDA review time
344 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K161316 | George King Coumadin Plasma | George King Bio-Medical, Inc. | 2017-02-23 | 288 | 0 |
| K945854 | B-FACT, BORDERLINE FACTOR ASSAY CONTROL | George King Bio-Medical, Inc. | 1995-10-24 | 344 | 0 |
| K945855 | A-FACT, ABNORMAL FACTOR ASSAY CONTROL | George King Bio-Medical, Inc. | 1995-10-24 | 344 | 0 |
| K945857 | PROTEIN C DEFICIENT PLASMA | George King Bio-Medical, Inc. | 1995-10-20 | 340 | 0 |
| K945856 | POSITIVE LUPUS ANTICOAGULANT PLASMA | George King Bio-Medical, Inc. | 1995-10-05 | 325 | 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