Company ยท US
Pentax of America, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 2012 to 2025. Name variants (Inc, Corp, punctuation) are merged.
44510(k) clearances (1 in 12 months)
38recalls (5 in 12 months)
30recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| EOQ | Bronchoscope (Flexible Or Rigid) | 14 |
| ODG | Endoscopic Ultrasound System, Gastroenterology-Urology | 12 |
| PEA | Endoscope, Accessories, Image Post-Processing For Color Enhancement | 11 |
| FDT | Duodenoscope And Accessories, Flexible/Rigid | 8 |
| GEH | Unit, Cryosurgical, Accessories | 8 |
| FDF | Colonoscope And Accessories, Flexible/Rigid | 7 |
| FDS | Gastroscope And Accessories, Flexible/Rigid | 6 |
| EOB | Nasopharyngoscope (Flexible Or Rigid) | 4 |
| GCW | Transformer, Endoscope | 4 |
| OUG | Medical Device Data System | 2 |
| EOX | Esophagoscope (Flexible Or Rigid) | 1 |
| EQL | Laryngostroboscope | 1 |
| FAJ | Cystoscope And Accessories, Flexible/Rigid | 1 |
| FET | Endoscopic Video Imaging System/Component, Gastroenterology-Urology | 1 |
| ODC | Endoscope Channel Accessory | 1 |
| PCV | Endoscopic Leak Tester | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Dec 16, 2025 | K251256 | PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family) Pentax of America, Inc. | FDS |
| Jun 3, 2025 | K251127 | PENTAX Medical Video Processor (EPK-i8020c) Pentax of America, Inc. | PEA |
| Jan 3, 2025 | K242110 | PENTAX Medical Video Colonoscope (EC38-i20cWL) Pentax of America, Inc. | FDF |
| Dec 6, 2024 | K241213 | PENTAX Medical Video Upper GI Scope (EG27-i20c); PENTAX Medical Video Colonoscope (EC34-i20cL) Pentax of America, Inc. | FDS |
| Aug 1, 2024 | K233942 | PENTAX Medical Video Duodenoscope (ED34-i10T2s); PENTAX Medical Video Processor (EPK-i8020c); PENTAX Medical Single Use, Pentax of America, Inc. | FDT |
| Jul 24, 2024 | K240457 | C2 CryoBalloon Ablation System (C2 CryoBalloon Ablation System) Pentax of America, Inc. | GEH |
| Jan 18, 2024 | K232860 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Bronchoscope EB11-J10, PENTAX Medical Video Bronchoscope Pentax of America, Inc. | EOQ |
| Jan 12, 2024 | K231970 | PENTAX Medical Single Use Video Bronchoscope EB11-S01, PENTAX Medical Single Use Video Bronchoscope EB15-S01, PENTAX Med Pentax of America, Inc. | EOQ |
| Dec 1, 2023 | K232249 | PENTAX Medical Gas/Water Feeding Valve OE-B14 Pentax of America, Inc. | ODC |
| Jul 28, 2023 | K231249 | PENTAX Medical Video Processor EPK-i8020c, PENTAX Medical Video Upper GI Scope EG29-i20c, PENTAX Medical Video Colonosco Pentax of America, Inc. | PEA |
| Dec 21, 2022 | K213235 | PENTAX Medical ONE Pulmo Single Use Video Bronchoscope System Pentax of America, Inc. | EOQ |
| Dec 2, 2022 | K223072 | PENTAX Medical Video Esophagoscope EE17-J10 Pentax of America, Inc. | EOX |
| Nov 16, 2022 | K220465 | PENTAX Medical EPK-3000 Imaging System with Camera Head PVK-J10, PENTAX Medical ENT Imaging System with Camera Head PVK- Pentax of America, Inc. | EOB |
| Nov 29, 2021 | K212814 | C2 CryoBalloon Ablation System Pentax of America, Inc. | GEH |
| Oct 21, 2021 | K210928 | PENTAX Medical Video Bronchoscope EB11-J10 Pentax of America, Inc. | EOQ |
| Oct 20, 2021 | K210177 | PENTAX Medical Video Upper GI Scopes EG17-J10 Pentax of America, Inc. | FDS |
| Oct 1, 2021 | K212201 | PENTAX Medical Auto Leakage Tester SHA-P6 Pentax of America, Inc. | PCV |
| May 13, 2021 | K210485 | PENTAX Medical Video Upper GI Scopes (EG Family), PENTAX Medical Video Colonoscopes (EC Family) Pentax of America, Inc. | FDS |
| Apr 9, 2021 | K210710 | PENTAX Medical Video Duedenoscope ED34-i10T2 Pentax of America, Inc. | FDT |
| Apr 1, 2021 | K202365 | Pentax Medical Video Duodenoscope ED32-i10 Pentax of America, Inc. | FDT |
| Dec 30, 2020 | K203166 | PENTAX Medical Ultrasound Upper GI Video Scope EG34-J10U, PENTAX Medical Ultrasound Upper GI Video Scope EG36-J10UR, PEN Pentax of America, Inc. | ODG |
| Nov 24, 2020 | K203024 | C2 CryoBalloon Catheter (Pear), C2 CryoBalloon Catheter (Standard), C2 CryoBalloon Controller, C2 CryoBalloon Foot Pedal Pentax of America, Inc. | GEH |
| Jul 30, 2020 | K200678 | PENTAX Medical Video Bronchoscope EB-J10 Series Pentax of America, Inc. | EOQ |
| Jul 23, 2020 | K200090 | PENTAX Medical EG-J10U Endoscopic Ultrasound System - EG34-J10U Ultrasound Upper GI Video Scope (Convex Array Type), EG3 Pentax of America, Inc. | ODG |
| Dec 20, 2019 | K190805 | PENTAX Medical Video Processor EPK-i5500c, PENTAX Medical Video Upper GI Scope EG29-i10c, PENTAX Medical Video Colonosco Pentax of America, Inc. | PEA |
| Nov 15, 2019 | K192245 | Pentax Medical Video Duodenoscope ED34-i10T2 Pentax of America, Inc. | FDT |
| Nov 12, 2019 | K190799 | PENTAX Medical Video Upper GI Scopes (EG Family) Pentax of America, Inc. | FDS |
| Nov 8, 2019 | K191282 | PENTAX Medical EPK-i7010 and PENTAX EPK-i5010 Video Processors with GI Family Pentax of America, Inc. | PEA |
| Sep 6, 2019 | K183516 | PENTAX Medical Ultrasound Video Bronchoscope EB19-J10U Pentax of America, Inc. | EOQ |
| Jun 12, 2019 | K183691 | PENTAX Medical ENT Video Imaging System Pentax of America, Inc. | EOB |
| May 23, 2019 | K183654 | PENTAX Medical EB-1970UK Ultrasound Video Bronchoscope + Hitachi NOBLUS and HI VISION Preirus Pentax of America, Inc. | EOQ |
| Jan 18, 2019 | K181084 | PENTAX Video Colonoscopes (EC Family) Pentax of America, Inc. | FDF |
| Jan 9, 2019 | K182846 | PENTAX Medical EPK-3000 Video Imaging System Pentax of America, Inc. | EOB |
| Aug 21, 2018 | K182004 | PENTAX Medical Endoscopic Ultrasound System Pentax of America, Inc. | ODG |
| Jul 9, 2018 | K181522 | PENTAX MEDICAL ED-3490TK, Video Duodenoscope, PENTAX Medical ED34-i10T, Video Duodenoscope Pentax of America, Inc. | FDT |
| Jul 3, 2018 | K173679 | PENTAX Medical EPK-i7010 Video Processor with EB Family of Scopes Pentax of America, Inc. | PEA |
| Jan 19, 2018 | K173554 | PENTAX Medical Video Bronchoscopes, PENTAX Medical Video Naso-Pharyngo-Laryngoscope, and PENTAX Medical Ultrasond Video Pentax of America, Inc. | EOQ |
| Apr 20, 2017 | K162151 | PENTAX Medical ENT Video Imaging System Pentax of America, Inc. | EOB |
| Apr 13, 2017 | K162447 | PENTAX Medical Endoscopic Ultrasound System, EG-3270UK Upper G.I. Video Scope (Convex Array Type) with EPK-i5010 Video P Pentax of America, Inc. | ODG |
| Nov 24, 2015 | K150618 | PENTAX Medical EPK-i7010 Video Processor with GI Family Pentax of America, Inc. | PEA |
| Oct 29, 2015 | K143727 | PENTAX Medical EKP-i5010 Video Processor with EB Family Pentax of America, Inc. | EOQ |
| Mar 20, 2013 | K130247 | PENTAX EG-3870UTK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS Pentax of America, Inc. | ODG |
| Mar 20, 2013 | K130206 | PENTAX EG-3670URK ULTRASOUND VIDEO GASTROSCOPE + HI VISION PREIRUS Pentax of America, Inc. | ODG |
| Jun 22, 2012 | K113873 | PENTAX EPK-I5020 VIDEO PROCESSOR Pentax of America, Inc. | FET |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Water bottle assembly. Model Number. OS-H5. Open, Classified |
PEA | K191282 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG-3270UK. Open, Classified |
ODG | K182004 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG-3870UTK, EG-3670URK. Open, Classified |
ODG | K182004 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Numbers. EG38-J10UT, EG34-J10U. Open, Classified |
ODG | K200090 |
| Oct 28, 2026 | Pentax of America Inc PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. Open, Classified |
ODG | K200090 |
| Aug 15, 2025 | Pentax of America Inc Pentax Medical Video Processor;
Model Number: EPK-i8020c; Open, Classified |
PEA | K231249 K251127 |
| Feb 26, 2025 | Pentax of America Inc Pentax Medical Video Processor- Intended to be used with PENTAX Medical endoscopes, monitors and other peripheral devices for endoscopic diagnosis, treatment, and video observation.
Model: EPK-i8020c Open, Classified |
PEA | K231249 |
| Feb 26, 2025 | Pentax of America Inc PENTAX Medical Video Upper GI Scope-Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract
Model: EG29-i20c Open, Classified |
PEA | K231249 |
| Feb 26, 2025 | Pentax of America Inc PENTAX Medical Video Colonoscope- Intended to provide optical visualization of (via a video monitor), and therapeutic access to the lower gastrointestinal tract
Model: EC38-i20cL Open, Classified |
PEA | K231249 |
| Jul 14, 2021 | Pentax of America Inc Gastroscope Family # 1-Gastroscopes without a Water Jet Channel
Models: EG-2790i, EG-1690K, EG-2490K, EG-2790K, EG27-i10;
Gastroscope Family # 2- Gastroscopes with a Water Jet Channel
Models: EG-2990i Open, Classified |
FDF | K131855 K181084 +1 |
| Jul 14, 2021 | Pentax of America Inc Colonoscope Family # 1-Pentax Video Colonoscopes (EC Family) with One Instrument Channel and a Water Jet Channel
Models:
EC-2990Li, EC-3490Li, EC-3890Li, EC-3490TLi, EC-3490LK, EC-3890LK, EC3890LZi, Open, Classified |
FDF | K131855 K181084 +1 |
| Apr 21, 2021 | Pentax of America Inc Pentax Medical Video Duodenoscope - Product Usage: intended to be used with endoscopic devices and other ancillary equipment to provide optical visualization of (via a video monitor), and therapeutic Terminated |
FDT | K192245 K210710 |
| Oct 23, 2020 | Pentax of America Inc 9310HD Digital Video Capture Module with software version 3.4.0 or higher configured with 9263 endoPortal Terminated |
OUG | None listed |
| Oct 23, 2020 | Pentax of America Inc 9372HD Digital Capture (ver. 1.1.0 + w/ 9263 endoPortal), Terminated |
OUG | None listed |
| Jan 3, 2020 | Pentax of America Inc Pentax Video Colonoscope
Model: EC38-i10L Terminated |
FDF | K131855 |
| Jan 3, 2020 | Pentax of America Inc Pentax Video Colonoscope
Model: EC34-i10L Terminated |
FDF | K131855 |
| Dec 3, 2018 | PENTAX of America Inc Pentax Medical C2 CryoBalloon Standard 90 degree Catheter, Model FG 1030, Sterile, RX.
Product Usage:
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of Terminated |
GEH | K163684 |
| Dec 3, 2018 | PENTAX of America Inc Pentax Medical C2 CryoBalloon Pear Focal Catheter, Model FG 1024, Sterile, RX.
Product Usage:
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general Terminated |
GEH | K163684 |
| Dec 3, 2018 | PENTAX of America Inc Pentax Medical C2 CryoBalloon Standard Focal Catheter, Model FG 1028, Sterile, RX.
Product Usage:
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of gene Terminated |
GEH | K163684 |
| Dec 3, 2018 | PENTAX of America Inc C2 CryoBalloon Controller, REF: FG-1017, with Controller Software v1.18.258
The C2 CryoBalloon Ablation System is intended to be used as a cryosurgical tool in the field of general surgery, specifica Terminated |
GEH | K163684 |
| Jun 5, 2018 | PENTAX of America Inc C2 CryoBalloon Focal Catheter, REF FG-1009. C2 CryoBalloon Ablation System is used as a cryosurgical tool in the field of general surgery, specifically for endoscopic applications. Terminated |
GEH | K131523 |
| Feb 20, 2018 | Pentax of America Inc Pentax Video Duodenoscope Model: ED-3490TK (UDI of design being recalled: 04961333232420)
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic ac Terminated |
FDT | K092710 K161222 |
| Jul 13, 2017 | Pentax of America Inc Video Cystoscope models ECY-1570 and ECY-1570K Terminated |
FAJ | None listed |
| May 23, 2017 | Pentax of America Inc Ultrasound Video Gastroscope, Model EG-3870UTK.
The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical video Terminated |
ODG | K090197 K130247 |
| May 23, 2017 | Pentax of America Inc Ultrasound Video Gastroscope, Model EG-3670URK,
The product is intended to be used in combination with the ultrasound scanning unit made by Hitachi Medical Corporation, and the PENTAX Medical vide Terminated |
ODG | K061068 K090196 +1 |
| Apr 13, 2017 | Pentax of America Inc 9200C and 9200D
Laryngeal Strobe
Product Usage:
The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, Terminated |
GCW | None listed |
| Apr 13, 2017 | Pentax of America Inc 9400
Laryngeal Strobe
Product Usage:
The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio data, for medica Terminated |
GCW | None listed |
| Apr 13, 2017 | Pentax of America Inc 9310HD
Digital Video Capture Modules
Product Usage:
The 9310HD is used to electronically record, display, transfer, and store digital video data of laryngeal or pharyngeal structures, and audio d Terminated |
GCW | None listed |
| Apr 13, 2017 | Pentax of America Inc 7245C, 7245C/E, 7245D
Computer Digital Video System
Product Usage:
The 7245C, 7245C/E and 7245D are used to electronically record, display, transfer, and store digital video data of behavior rela Terminated |
GCW | None listed |
| Jan 17, 2017 | Pentax of America Inc Video Duodenoscope
These instruments are intended to provide optical visualization of (via a video monitor), and therapeutic access to, the biliary tract via the upper GI tract. This anatomy includ Terminated |
FDT | K092710 K963056 |
| Dec 12, 2016 | Pentax of America Inc Rigid Laryngostroboscopes
The Rigid Laryngostroboscopes, Models 9106 and 9108 are intended to observe glottic action with the use of a stroboscopic light source. The instrument is inserted per-orally Terminated |
EQL | None listed |
| Nov 19, 2016 | Pentax of America Inc Pentax Video Colonoscope is intended to be used with a PENTAX video processor (including light source), documentation equipment, Monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancilla Terminated |
FDF | K131855 |
| Oct 26, 2016 | Pentax of America Inc Pentax Video Gastroscope is intended to be used with a Pentax video processor (including light source), documentation equipment, monitor, EndoTherapy Device such as a Biopsy Forceps, and other ancilla Terminated |
FDS | K131902 |
| May 31, 2016 | Pentax of America Inc Ultrasound Video Bronchoscope
The EB-1970UK, Ultrasound Video Bronchoscope, is intended to provide optical visualization of, ultrasonic visualization of, and therapeutic access to, the Pulmonary Trac Terminated |
EOQ | K131946 |
| May 31, 2016 | Pentax of America Inc Pentax Video Bronchoscope
Designed to be used with a Pentax Video Processor (including light source), documentation equipment, video monitor, endo-therapy accessories (such as biopsy forceps) and oth Terminated |
EOQ | K131028 |
| Jan 11, 2011 | Pentax of America Inc Video Naso pharyngo Laryngoscopes Terminated |
EOQ | K131028 K131946 |
| Jan 11, 2011 | Pentax of America Inc Video Cytoscopes Terminated |
EOQ | K131028 K131946 |
| Jan 11, 2011 | Pentax of America Inc Video Bronchoscope Terminated |
EOQ | K131028 K131946 |