Medical device manufacturer

Olympus Corporation

Olympus Corporation holds 149 FDA 510(k) clearances across 85 product codes. Median elapsed review time is 88 days. openFDA lists no recall records naming the company. FDA publishes it under 3 different spellings, all counted here as one company.

Updated 11 August 2026 · ingest status · JSON

510(k) clearances: 149
Product codes: 85
Median review: 88 days
Recall records: 0

How does FDA spell Olympus Corporation?

FDA publishes this company under 3 different spellings across its datasets. Every figure on this page counts all of them as one company, which is why the totals here are higher than a search for any single spelling would give you.

Every spelling FDA published for this company, and which dataset each came from.
As FDA published it	Dataset	Matched by
Olympus	device/510k	normalised
Olympus Corp.	device/510k	normalised
Olympus Corporation	device/510k	normalised

Merges are measured against a hand-labelled sample and held above 98% precision. Pairs the matcher is unsure of are queued for a person rather than merged, because two genuinely different firms with similar names is the error that would corrupt every count on this page.

Which product codes does Olympus Corporation file in?

85 product codes, ranked by how much they file in each.

Product codes this company holds clearances in, with their median elapsed review time in each.
Code	Device	Clearances	Median review	Latest
CGX	Alkaline Picrate, Colorimetry, Creatinine	6	56 days	16 November 1993
CHJ	Mercuric Thiocyanate, Colorimetry, Chloride	6	78 days	5 November 1993
EOQ	Bronchoscope (Flexible Or Rigid)	5	88 days	19 April 2004
JJE	Analyzer, Chemistry (Photometric, Discrete), For Clinical Use	5	44 days	31 August 1993
CIG	Diazo Colorimetry, Bilirubin	4	61 days	3 December 1992
HIH	Hysteroscope (And Accessories)	4	201 days	8 June 1994
CDQ	Urease And Glutamic Dehydrogenase, Urea Nitrogen	3	70 days	19 August 1993
CEO	Phosphomolybdate (Colorimetric), Inorganic Phosphorus	3	44 days	8 September 1993
EWY	Mediastinoscope, Surgical	3	88 days	16 March 1993
FGE	Stents, Drains And Dilators For The Biliary Ducts	3	151 days	5 April 1995
FJL	Resectoscope	3	256 days	21 June 1994
KNS	Unit, Electrosurgical, Endoscopic (With Or Without Accessories)	3	68 days	1 October 1990
CDT	Lipase Hydrolysis/Glycerol Kinase Enzyme, Triglycerides	2	42 days	28 October 1992
CEK	Biuret (Colorimetric), Total Protein	2	58 days	29 December 1992
CFJ	Nad Reduction/Nadh Oxidation, Lactate Dehydrogenase	2	47 days	16 November 1992
CFR	Hexokinase, Glucose	2	65 days	3 December 1992
CGS	Nad Reduction/Nadh Oxidation, Cpk Or Isoenzymes	2	48 days	4 January 1993
CGZ	Electrode, Ion-Specific, Chloride	2	49 days	11 August 1989
CHH	Enzymatic Esterase--Oxidase, Cholesterol	2	95 days	8 February 1993
CIC	Cresolphthalein Complexone, Calcium	2	48 days	19 October 1992
CIT	Nadh Oxidation/Nad Reduction, Ast/Sgot	2	42 days	26 January 1993
CIX	Bromcresol Green Dye-Binding, Albumin	2	58 days	8 February 1993
CJE	Nitrophenylphosphate, Alkaline Phosphatase Or Isoenzymes	2	36 days	18 November 1992
CKA	Nadh Oxidation/Nad Reduction, Alt/Sgpt	2	42 days	5 February 1993
DWX	Stripper, Artery, Intraluminal	2	85 days	2 January 1990

Showing the 25 they file in most, of 85.

Median review is elapsed calendar days between date received and decision date, as published by FDA. It is not FDA review days — the two differ whenever the agency stops the clock for an additional information request.

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

Has Olympus Corporation had a recall?

openFDA lists no recall records naming this company. That is the absence of a record, not a guarantee — and it counts only recalls FDA has published under a spelling we resolved to this company.

Recall class comes from openFDA's enforcement endpoint, which does not carry every recall — where it is missing, none is shown rather than guessed. Recall class I is the most serious kind of recall; device class I is the least risky kind of device, and the two are never mixed here.

Source: openFDA device/recall · retrieved 2026-08-11T14:48:53Z

What has Olympus Corporation cleared recently?

Most recent 510(k) clearances for this company, newest first.
510(k)	Device	Code	Decision	Elapsed days
K072643	CRYSTALEYE SPECTROPHOTOMETER/CRYSTALEYE BASIC SET, MODEL CE100-DC/US	KZN	16 November 2007	59
K043128	OLYMPUS ENDOARM	GWG	21 December 2004	39
K042140	OLYMPUS BF TYPE UC160-OL8	ODG	18 August 2004	9
K041494	OLYMPUS INTEGRATED ENDOSURGERY SYSTEM ENDOALPHA (CONTROL UNIT FOR ENDOSURGERY UCES-2) SOFTWARE VERSION 2	FET	1 July 2004	27
K040940	BRONCHOVIDEOSCOPE OLYMPUS XBF-D160HM	EOQ	19 April 2004	7
K915402	EW-10 AND EW-20	FEB	23 June 1995	1,297
K933200	OLYMPUS PBD STENTS	FGE	5 April 1995	643
K942338	OLYMPUS PF-8P OES PANCREATO FIBERSCOPE AND ACCESSORIES	FDT	30 November 1994	198
K931763	HF-RESECTION ELECTRODE, LOOP W/RUNNER ENDOS/ACCESS	FAS	29 August 1994	508
K934835	FLOVAL	FJL	21 June 1994	256

Source: openFDA device/510k · retrieved 2026-08-11T14:48:53Z

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Data on this page comes from FDA's public openFDA API and is US public domain (CC0). DeviceSignal is an independent commercial service and is not affiliated with the U.S. Food and Drug Administration. Information only, not regulatory advice. Verify anything you rely on against open.fda.gov.