Data / Medical devices / Japan / HOYA Corporation PENTAX Lifecare Division

HOYA Corporation PENTAX Lifecare Division: FDA-registered device maker in KURIHARA-SHI Miyagi, Japan, 53 510(k) clearances

Name: HOYA Corporation PENTAX Lifecare Division FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

HOYA Corporation PENTAX Lifecare Division is registered with the FDA (registration 3003782610) in KURIHARA-SHI Miyagi, Japan. It lists 29 device types. The FDA files 53 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.

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Get makers like this one Watch HOYA Corporation PENTAX Lifecare Division

FDA registration number: 3003782610
Address: 30-2 Okada, Aza-Shimomiyano, Tsukidate, KURIHARA-SHI Miyagi, Japan, 987-2203
Owner or operator: HOYA Corporation PENTAX Division (8030235)
Roles: Exporter to the US, Manufacturer
First device listed: March 9, 2002
Registered through: 2026
Brand names listed: 2CH CLEANING ADAPTER (OF-B162), 300W XENON LAMP KIT W/HOUSING- EPK-I5010 (OL-X27), A/W VALVE (OF-B188), A/W, S & FWJ CYLINDER CLEANING (CS-C5S), ADAPTER SLEEVE FOR FIBERSCOPE (OF-G1), ADAPTER, AIR/WATER/SUCTION CHANNEL (OE-C5), ADAPTER, CO2 GAS (OF-G11), ADAPTER, EYEPIECE/RIGID OCULAR (AP-RV3) and more

Devices it lists

Device	Product code	Class	Role	Source
Accessories, Cleaning Brushes, For Endoscope	MNL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Accessories, Photographic, For Endoscope (Exclude Light Sources)	FEM	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Attachment, Teaching, For Endoscope	FEA	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Bronchoscope (Flexible Or Rigid)	EOQ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Bulb, Inflation, For Endoscope	FCY	1	Exporter to the US	accessdata.fda.gov
Choledochoscope And Accessories, Flexible/Rigid	FBN	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Colonoscope And Accessories, Flexible/Rigid	FDF	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Cystoscope And Accessories, Flexible/Rigid	FAJ	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Duodenoscope And Accessories, Flexible/Rigid	FDT	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Electrosurgical, Cutting & Coagulation & Accessories	GEI	2	Exporter to the US	accessdata.fda.gov
Endoscope Channel Accessory	ODC	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscope, Accessories, Image Post-Processing For Color Enhancement	PEA	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Bite Block	MNK	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Irrigation/Suction System	OCX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Ultrasound System, Gastroenterology-Urology	ODG	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Endoscopic Video Imaging System/Component, Gastroenterology-Urology	FET	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Esophagoscope (Flexible Or Rigid)	EOX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Esophagoscope, General & Plastic Surgery	GCL	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Forceps, Biopsy, Electric	KGE	2	Exporter to the US	accessdata.fda.gov
Gastroscope And Accessories, Flexible/Rigid	FDS	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Laryngoscope, Non-Rigid	CAL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Laryngostroboscope	EQL	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Light Source, Fiberoptic, Routine	FCW	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Medical Device Data System	OUG	1	Exporter to the US, Manufacturer	accessdata.fda.gov
Nasopharyngoscope (Flexible Or Rigid)	EOB	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Sigmoidoscope And Accessories, Flexible/Rigid	FAM	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Snare, Flexible	FDI	2	Exporter to the US	accessdata.fda.gov
Transducer, Ultrasonic, Diagnostic	ITX	2	Exporter to the US, Manufacturer	accessdata.fda.gov
Ureteroscope And Accessories, Flexible/Rigid	FGB	2	Exporter to the US, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
December 16, 2025	K251256	PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)	FDS	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
June 3, 2025	K251127	PENTAX Medical Video Processor (EPK-i8020c)	PEA	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
January 3, 2025	K242110	PENTAX Medical Video Colonoscope (EC38-i20cWL)	FDF	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
December 6, 2024	K241213	PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL)	FDS	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
August 1, 2024	K233942	PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Sterile Distal End Cap with Elevator (OE-A63); Gas/Water Feeding Valves (OF-B194 )	FDT	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
December 1, 2023	K232249	PENTAX Medical Gas/Water Feeding Valve OE-B14	ODC	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
July 28, 2023	K231249	PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL	PEA	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
December 2, 2022	K223072	PENTAX Medical Video Esophagoscope EE17-J10	EOX	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
November 16, 2022	K220465	PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10	EOB	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
October 21, 2021	K210928	PENTAX Medical Video Bronchoscope EB11-J10	EOQ	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
October 20, 2021	K210177	PENTAX Medical Video Upper GI Scopes EG17-J10	FDS	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
April 1, 2021	K202365	Pentax Medical Video Duodenoscope ED32-i10	FDT	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
July 30, 2020	K200678	PENTAX Medical Video Bronchoscope EB-J10 Series	EOQ	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
July 23, 2020	K200090	PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG36-J10UR Ultrasound Upper GI Video Scope (Radial Array Type), EG38-J10UT Ultrasound Upper GI Video Scope (Convex Array Type)	ODG	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
December 20, 2019	K190805	PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonoscope EC34-i10cL, PENTAX Medical Video Colonoscope EC38-i10cL	PEA	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
November 15, 2019	K192245	Pentax Medical Video Duodenoscope ED34-i10T2	FDT	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
November 8, 2019	K191282	PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family	PEA	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
September 6, 2019	K183516	PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U	EOQ	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
October 26, 2018	K180285	PENTAX Medical Video Colonoscope EC34-i10T Series	FDF	Substantially Equivalent	Pentax Medical of America, Inc.	accessdata.fda.gov
October 12, 2018	K180292	PENTAX Video Upper G.I. Scope EG34-i10	FDS	Substantially Equivalent	Pentax Medical of America, Inc.	accessdata.fda.gov
August 21, 2018	K182004	PENTAX Medical Endoscopic Ultrasound System	ODG	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
April 5, 2018	K172156	PENTAX Medical EPK-3000 Video Imaging System	EOB	Substantially Equivalent	Pentax Medical	accessdata.fda.gov
September 20, 2017	K163614	PENTAX Medical ED34-i10T, Video Duodenoscope	FDT	Substantially Equivalent	Pentax Medical	accessdata.fda.gov
April 20, 2017	K162151	PENTAX Medical ENT Video Imaging System	EOB	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
April 13, 2017	K162447	PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video Processor and HI VISION Preirus Ultrasound Scanner	ODG	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
November 24, 2015	K150618	PENTAX Medical EPK-i7010 Video Processor with GI Family	PEA	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
April 25, 2014	K131946	ENTAX ULTRASOUND VIDEO BRONCHOSCOPE EB-1970UK + HI VISIN PREIRUS	EOQ	Substantially Equivalent	Pentax Medical Company	accessdata.fda.gov
April 10, 2014	K131902	PENTAX VIDEO UPPER G.I. SCOPES (EG FAMILY)	FDS	Substantially Equivalent	Pentax Medical Company	accessdata.fda.gov
April 10, 2014	K131028	PENTAX VIDEO BRONCHOSCOPES (EB FAMILY)	EOQ	Substantially Equivalent	Pentax Medical Company	accessdata.fda.gov
April 9, 2014	K131855	PENTAX VIDEO COLONOSCOPES (EC FAMILY)	FDF	Substantially Equivalent	Pentax Medical Company	accessdata.fda.gov
April 10, 2013	K122470	PENTAX EPK-I5010 VIDEO PROCESSOR	PEA	Substantially Equivalent	Pentax Medical	accessdata.fda.gov
March 20, 2013	K130247	PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS	ODG	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
March 20, 2013	K130206	PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS	ODG	Substantially Equivalent	Pentax of America, Inc.	accessdata.fda.gov
June 9, 2004	K041397	EG-3830UT	ITX	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
February 11, 2003	K023401	EG-3830UT, VIDEO ULTRASOUND GASTROSCOPE	ODG	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
October 16, 2002	K023376	EB-1830T3, VIDEO BRONCHOSCOPE	EOQ	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
April 17, 2001	K010740	FG-36UX, FIBER ULTRASOUND GASTROSCOPE	ODG	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
October 10, 1996	K963056	ED-3410, VIDEO DUODENOSCOPE	FDT	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
October 4, 1996	K962897	EG-3400, VIDEO GASTROSCOPE	FDS	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
July 9, 1996	K961564	EG-2940, VIDEO GASTROSCOPE	FDS	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
June 19, 1996	K961563	EC-384OTL, VIDEO COLONSCOPE	FDF	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
March 21, 1996	K951579	EC-3800TL, VIDEO COLONOSCOPE	FDF	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
March 21, 1996	K951577	ES-3800, VIDEO SIGMOIDOSCOPE	FAM	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
March 21, 1996	K951574	EC-3800L, VIDEO COLONOSCOPE	FDF	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
November 3, 1995	K953286	FCP-9P, FIBER CHOLEDOCHOSCOPE	FBN	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
April 10, 1995	K951199	FB-18X, FIBER BRONCHOSCOPE	EOQ	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
April 7, 1995	K951196	FNL-10P, FIBER NASOPARHYNGOSCOPE	EOB	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
January 26, 1994	K934920	VB-1830/VB-1530, VIDEO BRONCHOSCOPE	EOQ	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
July 1, 1992	K921707	PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2	EOB	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
January 10, 1992	K914106	PENTAX URETERORENOFIBERSCOPE, MODEL FUR-10P	FGB	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
January 10, 1992	K914008	PENTAX CYSTOFIBERSCOPE, MODEL FCY-15P	FAJ	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
July 9, 1985	K850020	PENTAX PNE- ULTRA-SLIM UPPER G.I. FIBERSCOPE FG-23	FDS	Substantially Equivalent	Pentax Precision Instrument Corp.	accessdata.fda.gov
September 30, 1977	K771739	PENTAX LH-150F LIGHT SOURCE	FCW	Substantially Equivalent	Pilling Co.	accessdata.fda.gov

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Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.