Montvale, NJ, US · 24 510(k) clearances · 11 recalls
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 5 | 2024-01-18 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 4 | 2025-12-16 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 3 | 2024-08-01 |
| GEH | Unit, Cryosurgical, Accessories | Class II | General, Plastic Surgery | 3 | 2024-07-24 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | Class II | Gastroenterology, Urology | 2 | 2025-06-03 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | Class II | Gastroenterology, Urology | 2 | 2020-12-30 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | Class II | Gastroenterology, Urology | 1 | 2025-01-03 |
| ODC | Endoscope Channel Accessory | Class II | Gastroenterology, Urology | 1 | 2023-12-01 |
| EOX | Esophagoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 1 | 2022-12-02 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | Class II | Ear, Nose, Throat | 1 | 2022-11-16 |
| PCV | Endoscopic Leak Tester | Class II | Gastroenterology, Urology | 1 | 2021-10-01 |
| Date | Severity | Status | Recall # | Product | Code | Reason |
|---|---|---|---|---|---|---|
| 2025-07-16 | Class II | Ongoing | Z-2329-2025 | Pentax Medical Video Processor; Model Number: EPK-i8020c; | — | During endoscopic procedures using a combination of the video processor EPK-i8020c and i20c series video endoscope, the observed image can become reddish or dar… |
| 2025-01-29 | Class II | Ongoing | Z-1238-2025 | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral device… | — | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or… |
| 2025-01-29 | Class II | Ongoing | Z-1237-2025 | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic … | — | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or… |
| 2025-01-29 | Class II | Ongoing | Z-1236-2025 | PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic a… | — | During endoscopic procedures using a combination of the video processor EPK-i8020c and the i20c series video endoscope, the observed image can become reddish or… |
| 2021-07-14 | Class II | Ongoing | Z-2449-2021 | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10… | — | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families |
| 2021-07-14 | Class II | Ongoing | Z-2448-2021 | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel Models… | — | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families |
| 2021-04-21 | Class II | Terminated | Z-1682-2021 | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equip… | — | IFU updated: The warning section of the IFU for both the OE-A63 distal end cap and ED34-i10T2 duodenoscope has been updated to notify users of the associated ri… |
| 2020-09-22 | Class II | Terminated | Z-0293-2021 | 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal | — | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Pa… |
| 2020-09-22 | Class II | Terminated | Z-0292-2021 | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | — | There is an intermittent software issue that could affect the systems, in which an exam video for one patient (Patient A) might be copied to another patient (Pa… |
| 2020-01-03 | Class II | Terminated | Z-1268-2020 | Pentax Video Colonoscope Model: EC38-i10L | — | Distributed in the USA without an approved 510K |
| 2020-01-03 | Class II | Terminated | Z-1267-2020 | Pentax Video Colonoscope Model: EC34-i10L | — | Distributed in the USA without an approved 510K |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2025-12-16 | K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) | FDS | Class II | Gastroenterology, Urology |
| 2025-06-03 | K251127 | PENTAX Medical Video Processor (EPK-i8020c) | PEA | Class II | Gastroenterology, Urology |
| 2025-01-03 | K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | FDF | Class II | Gastroenterology, Urology |
| 2024-12-06 | K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | FDS | Class II | Gastroenterology, Urology |
| 2024-08-01 | 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 | Class II | Gastroenterology, Urology |
| 2024-07-24 | K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | GEH | Class II | General, Plastic Surgery |
| 2024-01-18 | 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 | Class II | Ear, Nose, Throat |
| 2024-01-12 | K231970 | 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 | EOQ | Class II | Ear, Nose, Throat |
| 2023-12-01 | K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | ODC | Class II | Gastroenterology, Urology |
| 2023-07-28 | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonoscope EC38-i20cL | PEA | Class II | Gastroenterology, Urology |
| 2022-12-21 | K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | EOQ | Class II | Ear, Nose, Throat |
| 2022-12-02 | K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | EOX | Class II | Ear, Nose, Throat |
| 2022-11-16 | K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK-J10 | EOB | Class II | Ear, Nose, Throat |
| 2021-11-29 | K212814 | C2 CryoBalloon Ablation System | GEH | Class II | General, Plastic Surgery |
| 2021-10-21 | K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | EOQ | Class II | Ear, Nose, Throat |
| 2021-10-20 | K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | FDS | Class II | Gastroenterology, Urology |
| 2021-10-01 | K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | PCV | Class II | Gastroenterology, Urology |
| 2021-05-13 | K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | FDS | Class II | Gastroenterology, Urology |
| 2021-04-09 | K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | FDT | Class II | Gastroenterology, Urology |
| 2021-04-01 | K202365 | Pentax Medical Video Duodenoscope ED32-i10 | FDT | Class II | Gastroenterology, Urology |
| 2020-12-30 | K203166 | 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 | ODG | Class II | Gastroenterology, Urology |
| 2020-11-24 | K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal, C2 CryoBalloon Cartridge | GEH | Class II | General, Plastic Surgery |
| 2020-07-30 | K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series | EOQ | Class II | Ear, Nose, Throat |
| 2020-07-23 | 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 | Class II | Gastroenterology, Urology |