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

Olympus America, Inc. — Predicate Candidate Screening

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

84 daysmedian FDA review time

282 days90th percentile

149clearances measured

K-number	Device	Applicant	Decided	Review days	Recalls (K-match)
K111788	ENDOEYE HD II	Olympus America, Inc.	2012-01-13	203	2
K081615	OLYMPUS CEA - CARCINOEMBRYONIC ANTIGEN	Olympus America, Inc.	2009-03-18	282	0
K073489	OLYMPUS IGA REAGENT	Olympus America, Inc.	2008-02-11	61	1
K073490	OLYMPUS IGG REAGENT	Olympus America, Inc.	2008-02-11	61	0
K073487	OLYMPUS IGM REAGENT	Olympus America, Inc.	2008-02-11	61	1
K062862	OLYMPUS URIC ACID REAGENT, MODEL OSR6X98	Olympus America, Inc.	2007-04-06	193	1
K063804	OLYMPUS TRIGLYCERIDE TEST SYSTEM	Olympus America, Inc.	2007-03-23	91	0
K061499	OSFERION	Olympus America, Inc.	2007-01-26	240	0
K062581	OLYMPUS TSH REAGENT, CALIBRATOR AND CONTROL AND AU3000I IMMU	Olympus America, Inc.	2006-11-29	90	0
K061575	OLYMPUS CALCIUM ARSENAZO REAGENT, OSR60117, OSR61117, OSR651	Olympus America, Inc.	2006-10-05	120	0
K060201	OLYMPUS RF LATEX CALIBRATOR, AND OLYMPUS RF LATEX REAGENT WI	Olympus America, Inc.	2006-06-06	131	0
K051564	OLYMPUS CRP LATEX REAGENT, OSR6199; OLYMPUS CRP LATEX CALIBR	Olympus America, Inc.	2005-08-22	69	0
K051541	GF-UE160-AL5 ULTRASOUND ENDOSCOPE	Olympus America, Inc.	2005-07-01	21	1
K043460	OLYMPUS LYOPHILIZED CHEMISTRY CALIBRATORS DR0070 AND DR0071	Olympus America, Inc.	2005-01-31	47	0
K043202	OLYMPUS CREATINE KINASE REAGENT OSR6179/OSR6279	Olympus America, Inc.	2004-12-23	35	0
K042406	OLYMPUS LACTATE, OSR6193	Olympus America, Inc.	2004-12-03	91	0
K041668	OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT	Olympus America, Inc.	2004-08-19	62	0
K041793	OLYMPUS UNSATURATED IRON BINDING CAPCITY REAGENT, OSR6124/0S	Olympus America, Inc.	2004-07-16	14	1
K040692	OLYMPUS HDL CHOLESTEROL REAGENT, OSR6195/OSR6295 AND OLYMPUS	Olympus America, Inc.	2004-04-08	22	0
K040471	OLYMPUS LDL CHOLESTEROL REAGENT, OSR6196/OSR6296; OLYMPUS LD	Olympus America, Inc.	2004-03-10	15	1
K032665	OLYMPUS LYOPHILIZED CALIBRATOR, MODELS DR0070 AND DR0071	Olympus America, Inc.	2003-11-21	85	0
K031380	OLYMPUS HBA1C REAGENT, (CATALOG NUMBER OSR6192), OLYMPUS HBA	Olympus America, Inc.	2003-11-14	197	1
K032285	OLYMPUS PREALBUMIN CALIBRATOR, ODR3029	Olympus America, Inc.	2003-08-21	28	0
K030045	OLYMPUS CHOLINESTERASE REAGENT (CATALOG NUMBER OSR6114)	Olympus America, Inc.	2003-02-21	46	0
K030124	OLYMPUS FERRITIN REAGENT	Olympus America, Inc.	2003-02-06	23	0
K021074	VISERA CYSTOVIDEOSCOPE OLYMPUS CYF TYPE V/VA	Olympus America, Inc.	2002-05-02	30	0
K021073	VISERA RHINLARYNGOVIDEOSCOPE OLYMPUS ENF TYPE V	Olympus America, Inc.	2002-05-01	29	0
K014032	OLYMPUS LDL CHOLESTEROL REAGENT, OLYMPUS LDL CHOLESTEROL CAL	Olympus America, Inc.	2002-02-08	64	0
K014015	OLYMPUS HDL CHOLESTEROL REAGENT; OLYMPUS HDL CHOLESTEROL CAL	Olympus America, Inc.	2002-02-08	65	0
K013066	HX-5/6-1 ENDOSCOPIC CLIPPING DEVICE	Olympus America, Inc.	2001-12-11	90	1
K011886	OLYMPUS EU-M60 EUS EXERA ENDOSCOPIC ULTRASOUND CTR, EUS EXER	Olympus America, Inc.	2001-08-27	73	0
K011720	OLYMPUS AU5400 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	2001-06-25	21	4
K001744	OLYMPUS ENDOSCOPIC LIGATION DEVICE	Olympus America, Inc.	2001-02-27	264	0
K003721	MODIFICATION TO OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	2000-12-18	14	4
K002982	OLYMPUS AU2700 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	2000-10-25	30	0
K002918	OLYMPUS CRP LATEX IMMUNOTURBIDIMETRIC REAGENT	Olympus America, Inc.	2000-10-25	36	0
K994103	OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY	Olympus America, Inc.	2000-09-05	274	0
K994106	OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY	Olympus America, Inc.	2000-06-02	179	0
K994069	OLYMPUS UM-S30-25R ULTRASONIC PROBE AND ASSOCIATED ANCILLARY	Olympus America, Inc.	2000-06-02	183	0
K991672	OLYMPUS NA-10J-KB ASPIRATION NEEDLE	Olympus America, Inc.	1999-11-03	170	0
K984358	OLYMPUS DISTAL ATTACHMENT, MODELS MH-462,-463,-464,-465,-466	Olympus America, Inc.	1999-09-17	284	2
K992086	OLYMPUS SERUM PROTEIN MULTICALIBRATOR 2	Olympus America, Inc.	1999-08-19	59	0
K990237	TROCAR SYSTEM ACCORDING TO HASSON	Olympus America, Inc.	1999-07-12	169	0
K991136	B-2-MICROGLOBULIN IMMUNOLOGICAL TEST SYSTEM	Olympus America, Inc.	1999-05-11	36	0
K984417	BIPOLAR GRASPING FORCEPS BIQ+	Olympus America, Inc.	1999-02-24	76	0
K982323	OLYMPUS UM 2R/3R ULTRASONIC PROBES AND ASSOCIATED ANCILLARY	Olympus America, Inc.	1998-12-11	162	0
K982725	OLYMPUS MH-246R BALLOON SHEATH, FOR FEMALE REPRODUCTIVE TRAC	Olympus America, Inc.	1998-10-23	79	0
K982289	HEAT PROBE UNIT HPU-20, HEAT PROBE CD-110##/120##	Olympus America, Inc.	1998-08-19	50	0
K981743	OLYMPUS AU400 CLINICAL CHEMISTRY ANALYZER	Olympus America, Inc.	1998-06-09	22	4
K981305	OLYMPUS SERUM PROTEIN MULTICALIBRATOR	Olympus America, Inc.	1998-05-07	27	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