Pentax of America Inc
FDA Regulatory Profile
Pentax of America Inc appears in FDA public data with 33 recalls, 44 510(k) clearances, 9 FDA inspections, and 2 compliance actions on record. Its most recent recall (Z-2329-2025, Class II) was initiated on July 16, 2025. Its most recent 510(k) clearance was granted on December 16, 2025.
Summary
- Total Recalls
- 33
- 510(k) Clearances
- 44
- Inspections
- 9
- Compliance Actions
- 2
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2329-2025 | Class II | Pentax Medical Video Processor; Model Number: EPK-i8020c; | July 16, 2025 |
| Z-1237-2025 | Class II | PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monito | January 29, 2025 |
| Z-1238-2025 | Class II | Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and oth | January 29, 2025 |
| Z-1236-2025 | Class II | PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor | January 29, 2025 |
| Z-2448-2021 | Class II | Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water | July 14, 2021 |
| Z-2449-2021 | Class II | Gastroscope Family # 1-Gastroscopes without a Water Jet Channel Models: EG-2790i, EG-1690K, EG-2490K | July 14, 2021 |
| Z-1682-2021 | Class II | Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and o | April 21, 2021 |
| Z-0292-2021 | Class II | 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), | September 22, 2020 |
| Z-0293-2021 | Class II | 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoP | September 22, 2020 |
| Z-1268-2020 | Class II | Pentax Video Colonoscope Model: EC38-i10L | January 3, 2020 |
| Z-1267-2020 | Class II | Pentax Video Colonoscope Model: EC34-i10L | January 3, 2020 |
| Z-1326-2019 | Class II | Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX. Product Usage: Th | December 3, 2018 |
| Z-1325-2019 | Class II | Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX. Product Usage: | December 3, 2018 |
| Z-1327-2019 | Class II | Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX. Product Us | December 3, 2018 |
| Z-0970-2019 | Class II | C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258 The C2 CryoBalloon Ab | December 3, 2018 |
| Z-2256-2018 | Class II | C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgica | March 30, 2018 |
| Z-0643-2018 | Class II | Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420) These | February 13, 2018 |
| Z-0615-2018 | Class II | Video Cystoscope models ECY-1570 and ECY-1570K | July 13, 2017 |
| Z-3068-2017 | Class II | Ultrasound Video Gastroscope, Model EG-3870UTK. The product is intended to be used in combination | May 23, 2017 |
| Z-3067-2017 | Class II | Ultrasound Video Gastroscope, Model EG-3670URK, The product is intended to be used in combinatio | May 23, 2017 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC | December 16, 2025 |
| K251127 | PENTAX Medical Video Processor (EPK-i8020c) | June 3, 2025 |
| K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) | January 3, 2025 |
| K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) | December 6, 2024 |
| K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX | August 1, 2024 |
| K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) | July 24, 2024 |
| K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medica | January 18, 2024 |
| K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope | January 12, 2024 |
| K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 | December 1, 2023 |
| K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Med | July 28, 2023 |
| K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System | December 21, 2022 |
| K223072 | PENTAX Medical Video Esophagoscope EE17-J10 | December 2, 2022 |
| K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System w | November 16, 2022 |
| K212814 | C2 CryoBalloon Ablation System | November 29, 2021 |
| K210928 | PENTAX Medical Video Bronchoscope EB11-J10 | October 21, 2021 |
| K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 | October 20, 2021 |
| K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 | October 1, 2021 |
| K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) | May 13, 2021 |
| K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 | April 9, 2021 |
| K202365 | Pentax Medical Video Duodenoscope ED32-i10 | April 1, 2021 |