Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Vital Scientific N.V. · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
130 daysmedian FDA review time
170 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K022021 | VITAL SCIENTIFIC APTT, APTT & QUIKCOAG APTT | Vital Scientific N.V. | 2002-11-01 | 134 | 0 |
| K021976 | FIBRON-1, FIBRON-4, QUIKCOAG, FIBRON | Vital Scientific N.V. | 2002-10-25 | 130 | 0 |
| K022046 | VITAL SCIENTIFIC COAGULATION CONTROL,COAGULATION CONTROL LEV | Vital Scientific N.V. | 2002-07-23 | 29 | 0 |
| K020840 | VITAL SCIENTIFIC PT WITH CALCIUM | Vital Scientific N.V. | 2002-05-15 | 61 | 0 |
| K973628 | VITALAB FLEXOR/VITALAB SELECTRA 2/VITALAB VIVA | Vital Scientific N.V. | 1998-03-13 | 170 | 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