Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
Neirynck & Vogt NV · Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
43 daysmedian FDA review time
58 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K023477 | BIOLOY | Neirynck & Vogt NV | 2002-12-13 | 58 | 0 |
| K021971 | CERALOY | Neirynck & Vogt NV | 2002-08-01 | 45 | 0 |
| K021969 | CHROLOY | Neirynck & Vogt NV | 2002-07-30 | 43 | 0 |
| K021965 | CHROLOY SOLDER | Neirynck & Vogt NV | 2002-07-26 | 39 | 0 |
| K021968 | CERALOY SOLDER | Neirynck & Vogt NV | 2002-07-26 | 39 | 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