Atlas FDA

Predicate Research Report · generated 2026-08-22 · Print / save as PDF · Save to account

Optik — Predicate Candidate Screening

6 FDA 510(k) clearances under this manufacturer; the 50 most recent screened below.

160 daysmedian FDA review time
225 days90th percentile
6clearances measured
K-numberDeviceApplicantDecidedReview daysRecalls (K-match)
K933776OPTIK LAPAROSCOPEOptik1994-03-162250
K926166COAST VIDEO ENDOSCOPIC IMAGING SYSTEMOptik1993-06-011750
K896404TITAMED ANTWERP SYSTEMOptik1990-04-161600
K896589MANUAL SURGICAL INSTRUMENTS FOR TITAMED ANTWERPOptik1989-12-27360
K894557LIGHTSCOPE SETOptik1989-08-07180
K894558MINI LIGHTSCOPE SET, LIGHTSCOPE JR. SETOptik1989-08-07180

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