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

Oktas — Predicate Candidate Screening

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

83 daysmedian FDA review time

115 days90th percentile

7clearances measured

K-number	Device	Applicant	Decided	Review days
K970214	3 DIMENSIONAL VIDEO ENDOSCOPE	Oktas	1997-04-14	83
K970369	VISTA MINI CAMERA SYSTEM	Oktas	1997-04-14	73
K961182	3D SCOPE	Oktas	1996-07-19	115
K946171	VIDEO ENDOSCOPE SYSTEM WITH ZOOM	Oktas	1995-01-26	38
K944254	OKTAS STEREO VIEWING SYSTEM	Oktas	1994-11-30	91
K944256	OKTAS INTRA-ORAL DENTAL CAMERA	Oktas	1994-11-22	83
K941919	OKTAS ENDOSCOPY VIDEO CAMERA SYSTEM	Oktas	1994-06-17	58

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