Data / Medical devices / Japan / HOYA Corporation PENTAX Lifecare Division
HOYA Corporation PENTAX Lifecare Division: FDA-registered device maker in Akishima-shi Tokyo, Japan, 56 510(k) clearances
HOYA Corporation PENTAX Lifecare Division is registered with the FDA (registration 9610877) in Akishima-shi Tokyo, Japan. It lists 31 device types. The FDA files 56 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 9610877
- FEI number
- 3008185830
- Address
- Tsutsujigaoka 1-1-110, Akishima-shi Tokyo, Japan, 196-0012
- Owner or operator
- HOYA Corporation PENTAX Division (8030235)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- 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 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Accessories, Photographic, For Endoscope (Exclude Light Sources) | FEM | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Attachment, Teaching, For Endoscope | FEA | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Bulb, Inflation, For Endoscope | FCY | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Choledochoscope And Accessories, Flexible/Rigid | FBN | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Cystoscope And Accessories, Flexible/Rigid | FAJ | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Electrosurgical, Cutting & Coagulation & Accessories | GEI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscope Channel Accessory | ODC | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscope, Accessories, Image Post-Processing For Color Enhancement | PEA | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Bite Block | MNK | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Irrigation/Suction System | OCX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Esophagoscope, General & Plastic Surgery | GCL | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Forceps, Biopsy, Electric | KGE | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Gastrointesinal Lesion Software Detection System | QNP | 2 | Complaint file establishment, Manufacturer, Specification developer | accessdata.fda.gov |
| Gastroscope And Accessories, Flexible/Rigid | FDS | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Laryngostroboscope | EQL | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Light Source, Endoscope, Xenon Arc | GCT | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Light Source, Fiberoptic, Routine | FCW | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Medical Device Data System | OUG | 1 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Snare, Flexible | FDI | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Complaint file establishment, Specification developer | accessdata.fda.gov |
| Ureteroscope And Accessories, Flexible/Rigid | FGB | 2 | Complaint file establishment, Specification developer | 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 |
| January 18, 2024 | K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope EB15-J10, PENTAX Medical Video Bronchoscope EB19-J10U, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U | EOQ | 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 |
| July 18, 2018 | K171011 | PENTAX Medical VIVIDEO ENT Videoscope Solution | EOB | Substantially Equivalent | Pentax Medical | 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 |
| February 7, 1994 | K934918 | EPM-3300 VIDEO PROCESSOR | FET | 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 |
Compare with other makers
- All makers of Nasopharyngoscope (Flexible Or Rigid)
- All makers of Bronchoscope (Flexible Or Rigid)
- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of Endoscopic Ultrasound System, Gastroenterology-Urology
- All makers of Forceps, Biopsy, Electric
- All makers of Duodenoscope And Accessories, Flexible/Rigid
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.