Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Universal Reagents, Inc. — Predicate Candidate Screening
8 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
54 daysmedian FDA review time
146 days90th percentile
8clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K973143 | UNIVERSAL REAGENT FACTOR XII (TWELVE) DEFICIENT PLASMA | Universal Reagents, Inc. | 1997-09-25 | 34 | 0 |
| K972288 | FACTOR DEFICIENT PLASMAS - FACTOR IX (9) | Universal Reagents, Inc. | 1997-07-14 | 25 | 0 |
| K972286 | FACTOR DEFICIENT PLASMAS - FACTOR XI (11) | Universal Reagents, Inc. | 1997-07-14 | 25 | 0 |
| K970607 | UNIVERSAL REAGENT FACTOR VII DEFICIENT PLASMA | Universal Reagents, Inc. | 1997-04-25 | 66 | 0 |
| K970593 | UNIVERSAL REAGENT FACTOR VIII DEFICIENT PLASMA | Universal Reagents, Inc. | 1997-04-25 | 66 | 0 |
| K964459 | UNIVERSAL REAGENT FACTOR X DEFICIENT PLASMA | Universal Reagents, Inc. | 1996-12-18 | 41 | 0 |
| K964270 | UNIVERSAL REAGENT FACTOR V DEFICIENT PLASMA | Universal Reagents, Inc. | 1996-12-18 | 54 | 0 |
| K961929 | FACTOR DEFICIENT PLASMA | Universal Reagents, Inc. | 1996-10-10 | 146 | 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