Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account
First Scientific Limited — Predicate Candidate Screening
5 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.
58 daysmedian FDA review time
76 days90th percentile
5clearances measured
| K-number | Device | Applicant | Decided | Review days | Recalls (K-match) |
|---|---|---|---|---|---|
| K011521 | ORTHO VLC; ORTHO VLC CAPSULE | First Scientific Limited | 2001-08-01 | 76 | 0 |
| K011520 | RESTORE-X | First Scientific Limited | 2001-07-23 | 67 | 0 |
| K011517 | LUTE; CORE | First Scientific Limited | 2001-07-10 | 54 | 0 |
| K011295 | RESTORE-PF VIC; RESTORE-PF VLC CAPSULE | First Scientific Limited | 2001-06-27 | 58 | 0 |
| K011309 | LUTE VLC; CORE VLC | First Scientific Limited | 2001-06-22 | 53 | 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