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

Olympus Corporation — Predicate Candidate Screening

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

27 daysmedian FDA review time

59 days90th percentile

5clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K072643	CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE1	Olympus Corporation	2007-11-16	59	0
K043128	OLYMPUS ENDOARM	Olympus Corporation	2004-12-21	39	0
K042140	OLYMPUS BF TYPE UC160-OL8	Olympus Corporation	2004-08-18	9	0
K041494	OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNI	Olympus Corporation	2004-07-01	27	0
K040940	BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM	Olympus Corporation	2004-04-19	7	1

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