| PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) (K251256) | Pentax of America, Inc. | 2025-12-16 |
| PENTAX Medical Video Processor (EPK-i8020c) (K251127) | Pentax of America, Inc. | 2025-06-03 |
| PENTAX Medical Video Colonoscope (EC38-i20cWL) (K242110) | Pentax of America, Inc. | 2025-01-03 |
| PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) (K241213) | Pentax of America, Inc. | 2024-12-06 |
| 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 ) (K233942) | Pentax of America, Inc. | 2024-08-01 |
| C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) (K240457) | Pentax of America, Inc. | 2024-07-24 |
| 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 (K232860) | Pentax of America, Inc. | 2024-01-18 |
| PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Medical Mobile Processor ONE-M, PENTAX Medical Mobile Processor Plug-In ONE-Dock (K231970) | Pentax of America, Inc. | 2024-01-12 |
| PENTAX Medical Gas/Water Feeding Valve OE-B14 (K232249) | Pentax of America, Inc. | 2023-12-01 |
| PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL (K231249) | Pentax of America, Inc. | 2023-07-28 |
| PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System (K213235) | Pentax of America, Inc. | 2022-12-21 |
| PENTAX Medical Video Esophagoscope EE17-J10 (K223072) | Pentax of America, Inc. | 2022-12-02 |
| PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 (K220465) | Pentax of America, Inc. | 2022-11-16 |
| C2 CryoBalloon Ablation System (K212814) | Pentax of America, Inc. | 2021-11-29 |
| PENTAX Medical Video Bronchoscope EB11-J10 (K210928) | Pentax of America, Inc. | 2021-10-21 |
| PENTAX Medical Video Upper GI Scopes EG17-J10 (K210177) | Pentax of America, Inc. | 2021-10-20 |
| PENTAX Medical Auto Leakage Tester SHA-P6 (K212201) | Pentax of America, Inc. | 2021-10-01 |
| PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) (K210485) | Pentax of America, Inc. | 2021-05-13 |
| PENTAX Medical Video Duedenoscope ED34-i10T2 (K210710) | Pentax of America, Inc. | 2021-04-09 |
| Pentax Medical Video Duodenoscope ED32-i10 (K202365) | Pentax of America, Inc. | 2021-04-01 |
| PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PENTAX Medical Ultrasound Upper GI Video Scope EG38-J10UT, PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K203166) | Pentax of America, Inc. | 2020-12-30 |
| C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge (K203024) | Pentax of America, Inc. | 2020-11-24 |
| PENTAX Medical Video Bronchoscope EB-J10 Series (K200678) | Pentax of America, Inc. | 2020-07-30 |
| 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) (K200090) | Pentax of America, Inc. | 2020-07-23 |
| 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 (K190805) | Pentax of America, Inc. | 2019-12-20 |
| Pentax Medical Video Duodenoscope ED34-i10T2 (K192245) | Pentax of America, Inc. | 2019-11-15 |
| PENTAX Medical Video Upper GI Scopes (EG Family) (K190799) | Pentax of America, Inc. | 2019-11-12 |
| PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family (K191282) | Pentax of America, Inc. | 2019-11-08 |
| PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U (K183516) | Pentax of America, Inc. | 2019-09-06 |
| PENTAX Medical ENT Video Imaging System (K183691) | Pentax of America, Inc. | 2019-06-12 |
| PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus (K183654) | Pentax of America, Inc. | 2019-05-23 |
| PENTAX Video Colonoscopes (EC Family) (K181084) | Pentax of America, Inc. | 2019-01-18 |
| PENTAX Medical EPK-3000 Video Imaging System (K182846) | Pentax of America, Inc. | 2019-01-09 |
| PENTAX Medical Endoscopic Ultrasound System (K182004) | Pentax of America, Inc. | 2018-08-21 |
| PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope (K181522) | Pentax of America, Inc. | 2018-07-09 |
| PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes (K173679) | Pentax of America, Inc. | 2018-07-03 |
| PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Bronchoscope (K173554) | Pentax of America, Inc. | 2018-01-19 |
| PENTAX Medical ENT Video Imaging System (K162151) | Pentax of America, Inc. | 2017-04-20 |
| 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 (K162447) | Pentax of America, Inc. | 2017-04-13 |
| PENTAX Medical EPK-i7010 Video Processor with GI Family (K150618) | Pentax of America, Inc. | 2015-11-24 |
| PENTAX Medical EKP-i5010 Video Processor with EB Family (K143727) | Pentax of America, Inc. | 2015-10-29 |
| PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130206) | Pentax of America, Inc. | 2013-03-20 |
| PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS (K130247) | Pentax of America, Inc. | 2013-03-20 |
| PENTAX EPK-I5020 VIDEO PROCESSOR (K113873) | Pentax of America, Inc. | 2012-06-22 |