Data / Medical devices / Malaysia / Pentax Medical (penang) Sdn. Bhd.
Pentax Medical (penang) Sdn. Bhd.: FDA-registered device maker in Penang Pulau Pinang, Malaysia, 31 510(k) clearances
Pentax Medical (penang) Sdn. Bhd. is registered with the FDA (registration 3014605202) in Penang Pulau Pinang, Malaysia. It lists 12 device types. The FDA files 31 510(k) clearances under its listings, the newest dated December 16, 2025. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 3014605202
- Address
- Plot 554, Lorong Perusahaan 4 Prai Free Trade Zone, Penang Pulau Pinang, Malaysia, 13600
- Owner or operator
- HOYA Corporation PENTAX Division (8030235)
- Roles
- Exporter to the US
- First device listed
- January 4, 2006
- Registered through
- 2026
- Brand names listed
- 2CH CLEANING ADAPTER (OF-B162), A/W VALVE (OF-B188), ADAPTER, AIR/WATER/SUCTION CHANNEL (OE-C5), ADVANCED DIGITAL ULTRASOUND SYSTEM (HV-PREIRUS), AIR CLEANING BRUSH ADAPTER (OF-B170), AIR/WATER FEEDING VALVE FOR 70K/80K SERIES (OF-B183), AIR/WATER FEEDING VALVE FOR ULTRASOUND (OF-B172), AIR/WATER/SUCTION METAL OPTIONAL (OF-B153) and more
Devices it lists
| Device | Product code | Class | Role | Source |
|---|---|---|---|---|
| Bronchoscope (Flexible Or Rigid) | EOQ | 2 | Exporter to the US | accessdata.fda.gov |
| Colonoscope And Accessories, Flexible/Rigid | FDF | 2 | Exporter to the US | accessdata.fda.gov |
| Duodenoscope And Accessories, Flexible/Rigid | FDT | 2 | Exporter to the US | accessdata.fda.gov |
| Endoscope, Accessories, Image Post-Processing For Color Enhancement | PEA | 2 | Exporter to the US | accessdata.fda.gov |
| Endoscopic Ultrasound System, Gastroenterology-Urology | ODG | 2 | Exporter to the US | accessdata.fda.gov |
| Esophagoscope (Flexible Or Rigid) | EOX | 2 | Exporter to the US | accessdata.fda.gov |
| Gastroscope And Accessories, Flexible/Rigid | FDS | 2 | Exporter to the US | accessdata.fda.gov |
| Laryngoscope, Non-Rigid | CAL | 1 | Exporter to the US | accessdata.fda.gov |
| Laryngostroboscope | EQL | 1 | Exporter to the US | accessdata.fda.gov |
| Nasopharyngoscope (Flexible Or Rigid) | EOB | 2 | Exporter to the US | accessdata.fda.gov |
| Sigmoidoscope And Accessories, Flexible/Rigid | FAM | 2 | Exporter to the US | accessdata.fda.gov |
| Transducer, Ultrasonic, Diagnostic | ITX | 2 | Exporter to the US | 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
| March 21, 1996 | K951577 | ES-3800, VIDEO SIGMOIDOSCOPE | FAM | 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 |
| July 1, 1992 | K921707 | PENTAX NASO-PHARYNGO-LARYNGOSCOPE FNL-15P2/15RP2 | EOB | Substantially Equivalent | Pentax Precision Instrument Corp. | accessdata.fda.gov |
Compare with other makers
- All makers of Sigmoidoscope And Accessories, Flexible/Rigid
- All makers of Gastroscope And Accessories, Flexible/Rigid
- All makers of Colonoscope And Accessories, Flexible/Rigid
- All makers of Endoscopic Ultrasound System, Gastroenterology-Urology
- All makers of Transducer, Ultrasonic, Diagnostic
- 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.