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

Olympus Optical Co., Ltd. — Predicate Candidate Screening

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

81 daysmedian FDA review time

190 days90th percentile

22clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K033225	EVIS EXERA BRONCHOFIBERVIDEOSCOPE OLYMPUS BF TYPE XP160F, IT	Olympus Optical Co., Ltd.	2003-10-16	10	2
K031305	OLYMPUS ULTRASONIC SURGICAL SYSTEM	Olympus Optical Co., Ltd.	2003-09-23	152	0
K031648	VISERA RHINO-LARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V	Olympus Optical Co., Ltd.	2003-07-24	57	0
K032092	OLYMPUS XCYF-TP3 CYSTOFIBERSCOPE/NEPHROFIBERSCOPE	Olympus Optical Co., Ltd.	2003-07-16	9	0
K031347	ULTRASONIC GASTROVIDEOSCOPE, TYPE UC160P-AT8 AND UCT160-AT8	Olympus Optical Co., Ltd.	2003-05-09	10	0
K024138	HEAT SCISSORS GENERATOR SET AND HEAT SCISSORS HANDPIECE	Olympus Optical Co., Ltd.	2003-03-12	86	0
K021852	OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM & ITS ASSOCIATED ACCES	Olympus Optical Co., Ltd.	2003-02-11	251	0
K022445	VISERA HYSTEROVIDEOSCOPE OLYMPUS HYF TYPE V	Olympus Optical Co., Ltd.	2003-01-24	183	1
K024033	XTJF-160AF DUODENOVIDEOSCOPE	Olympus Optical Co., Ltd.	2002-12-20	14	0
K023280	OLYMPUS PSD-20 ELECTROSURGICAL SYSTEM AND ITS ASSOCIATED ACC	Olympus Optical Co., Ltd.	2002-12-19	79	0
K013759	MSS-28CS-301/701 NEEDLESCOPE	Olympus Optical Co., Ltd.	2002-08-20	280	0
K022270	MODIFICATION TO OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOAL	Olympus Optical Co., Ltd.	2002-08-14	30	0
K021179	DISPOSABLE GUIDEWIRE, MODELS G-205-3545S & G-205-3545A	Olympus Optical Co., Ltd.	2002-07-05	81	0
K014166	UHI-3 HIGH FLOW INSUFFLATION UNIT	Olympus Optical Co., Ltd.	2002-06-25	188	1
K021886	OLYMPUS ULTRASONIC GASTROVIDEOSCOPE GF TYPE UC140P-DO5 & OLY	Olympus Optical Co., Ltd.	2002-06-19	12	0
K021204	OLYMPUS BF TYPE UM40	Olympus Optical Co., Ltd.	2002-05-01	15	0
K013617	LTF-240 PLEURAVIDEOSCOPE, ITS ACCESSORIES AND ANCILLARY EQUI	Olympus Optical Co., Ltd.	2002-01-30	86	0
K013591	XENF-TP RHINO-LARYNGOFIBERSCOPE, ITS ACESSORIES AND ANCILLAR	Olympus Optical Co., Ltd.	2001-12-26	57	0
K011484	OLYMPUS INJECTOR NM-4-1, NM-5-1, NM-6-1, NM-7-1, NM-8-1, NM-	Olympus Optical Co., Ltd.	2001-08-10	88	0
K010591	OLYMPUS EU-C60 EUS EXERA COMPACT ENDOSCOPIC ULTRASOUND CENTE	Olympus Optical Co., Ltd.	2001-03-15	15	0
K002231	LF-DP GASTROINTESTINAL AND SIGMOID FIBERSCOPE, ACCESSORIES A	Olympus Optical Co., Ltd.	2001-01-30	190	0
K001766	OLYMPUS XGIF-N200H GASTROINTESTINAL VIDEOSCOPE	Olympus Optical Co., Ltd.	2000-09-08	88	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