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Olympus Corp. — Predicate Candidate Screening

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

88 daysmedian FDA review time

224 days90th percentile

142clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K915402	EW-10 AND EW-20	Olympus Corp.	1995-06-23	1297	0
K933200	OLYMPUS PBD STENTS	Olympus Corp.	1995-04-05	643	0
K942338	OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES	Olympus Corp.	1994-11-30	198	0
K931763	HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS	Olympus Corp.	1994-08-29	508	0
K934835	FLOVAL	Olympus Corp.	1994-06-21	256	0
K931764	HF RESECTION ELECTRODE, LOOP W/RUNNER HYSTER/ACCES	Olympus Corp.	1994-06-08	426	0
K915857	FLEXIBLE TIP THORACOSCOPE/LAPAROSCOPE	Olympus Corp.	1994-03-11	805	0
K931994	RESECTOSCOPE SHEATH	Olympus Corp.	1994-02-17	300	0
K933992	OLYMPUS SCLEROTHERAPY BALLOON	Olympus Corp.	1993-12-21	126	0
K934361	OLYMPUS CREATININE REAGENT	Olympus Corp.	1993-11-16	69	1
K934136	OLYMPUS CHLORIDE REAGENT, MODIFICATION	Olympus Corp.	1993-11-05	78	0
K933110	OLYMPUS GUIDE WIRE	Olympus Corp.	1993-11-04	132	0
K933717	OLYMPUS MEASURING DEVICES	Olympus Corp.	1993-11-02	95	0
K931301	OLYMPUS AMYLASE REAGENT	Olympus Corp.	1993-10-18	217	0
K931154	EVIS 200 SYSTEM	Olympus Corp.	1993-10-07	213	0
K931939	OLYMPUS CREATININE REAGENT	Olympus Corp.	1993-09-21	155	0
K932528	OLYMPUS CHLORID REAGENT, MODIFIED	Olympus Corp.	1993-09-17	148	0
K931835	OLYMPUS REPLY INORGANIC PHOSPHOROUS REAGENT	Olympus Corp.	1993-09-08	148	0
K931744	OLYMPUS REPLY GLUCOSE REAGENT	Olympus Corp.	1993-08-31	147	0
K931745	OLYMPUS REPLY UREA NITROGEN REAGENT	Olympus Corp.	1993-08-19	136	0
K926514	ENDOSCOPIC ULTRASOUND SYSTEM TYPE 20	Olympus Corp.	1993-08-16	229	0
K931995	RESECTOSCOPE SHEATH	Olympus Corp.	1993-07-23	91	18
K925935	OLYMPUS REPLY CLINICAL CHEMISTRY ANALYZER	Olympus Corp.	1993-04-22	154	0
K930241	OLYMPUS DISPOSABLE BIOPSY FORCEPS	Olympus Corp.	1993-04-20	91	0
K930215	FLEXIBLE TROCAR TUBES	Olympus Corp.	1993-03-16	61	0
K923982	OLYMPUS OES LAPAROSCOPY SYSTEM	Olympus Corp.	1993-03-15	220	1
K925603	OLYMPUS CHOLESTEROL REAGENT	Olympus Corp.	1993-02-08	95	1
K924368	OLYMPUS ALBUMIN REAGENT	Olympus Corp.	1993-02-08	164	0
K925339	OLYLMPUS ALANINE AMINOTRANSFERASE REAGENT	Olympus Corp.	1993-02-05	108	0
K925337	OLYMPUS GAMMA GLUTAMYL TRANSFERASE REAGENT	Olympus Corp.	1993-01-26	98	0
K925155	OLYMPUS ASPARTATE AMINOTRANSFERASE REAGENT	Olympus Corp.	1993-01-26	105	0
K925113	OLYMPUS URIC ACID REAGENT	Olympus Corp.	1993-01-26	109	0
K924832	OLYMPUS CREATINE KINASE REAGENT	Olympus Corp.	1993-01-04	101	0
K924659	OLYUMPUS TOTAL PROTEIN REAGENT	Olympus Corp.	1992-12-29	105	0
K924691	OLYMPUS IRON REAGENT	Olympus Corp.	1992-12-18	92	0
K925338	OLYMPUS CHLORIDE REAGENT	Olympus Corp.	1992-12-11	52	0
K924601	OLYMPUS GLUCOSE REAGENT	Olympus Corp.	1992-12-03	83	0
K924964	OLYMPUS TOTAL BILIRUBIN REAGENT	Olympus Corp.	1992-12-03	64	0
K924963	OLYMPUS DIRECT BILIRUBIN REAGENT	Olympus Corp.	1992-11-30	61	0
K924693	OLYMPUS BUN REAGENT	Olympus Corp.	1992-11-25	70	0
K925057	OLYMPUS INORGANIC PHOSPHORUS REAGENT	Olympus Corp.	1992-11-19	44	0
K922231	OLYMPUS CHOLESTEROL REAGENT	Olympus Corp.	1992-11-18	190	0
K925156	OLYMPUS ALKALINE PHOSPHATASE REAGENT	Olympus Corp.	1992-11-18	36	0
K924965	OLYMPUS LACTATE DEHYDROGENASE REAGENT	Olympus Corp.	1992-11-16	47	0
K924694	LIPASE HYDROLYSIS/GLYCEROT KINASE ENZYME, TRIGLYC	Olympus Corp.	1992-10-28	42	0
K924692	OLYMPUS CREATININE REAGENT	Olympus Corp.	1992-10-19	32	1
K924435	OLYMPUS CALCIUM REAGENT	Olympus Corp.	1992-10-19	48	0
K924658	OLYMPUS MAGNESIUM REAGENT	Olympus Corp.	1992-10-19	34	0
K924339	OLYMPUS AMYLASE REAGENT	Olympus Corp.	1992-10-19	52	0
K923609	OLYMPUS TOTAL BILIRUBIN REAGENT	Olympus Corp.	1992-10-02	79	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