Data / Medical devices / United States / PENTAX of America, Inc.
PENTAX of America, Inc.: FDA-registered device maker in Montvale, NJ, United States, 33 510(k) clearances
PENTAX of America, Inc. is registered with the FDA (registration 2518897) in Montvale, NJ, United States. It lists 36 device types. The FDA files 33 510(k) clearances under its listings, the newest dated July 6, 2018. 26 recall events name it as the recalling firm (1 Class I). Registered through 2026. FDA data exported November 3, 2026.
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- FDA registration number
- 2518897
- FEI number
- 1000080301
- Address
- 3 Paragon Drive, Montvale, NJ, United States, 07645
- Owner or operator
- HOYA Corporation PENTAX Division (8030235)
- Roles
- Complaint file establishment, Manufacturer, Specification developer
- First device listed
- January 6, 2006
- Registered through
- 2026
- Brand names listed
- 1.5 LITER CANISTER (67080), 150W HALOGEN LAMP (MU0P00000705), 1600VA Isolation Transformer (M80201), 2.5 LITER CANISTER (67081), 22" DELL LCD MONITOR (72066), 24" LCD MONITOR HD (MONITOR ST), 26" HD MEDICAL MONITOR (FSNP2604D), 27" RADIANCE ULTRA MONITOR (NDS90X0660) and more
Devices it lists
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 |
|---|---|---|---|---|---|---|
| July 6, 2018 | K181509 | Endorate Valve Sets | OCX | Substantially Equivalent | Smartdata Suzhou Co., Ltd. | accessdata.fda.gov |
| January 5, 2017 | K161202 | C2 Cryoballoon Ablation System | GEH | Substantially Equivalent | C2 Therapeutics, Inc. | accessdata.fda.gov |
| October 21, 2016 | K161773 | CapsoCam Plus (SV-3) Capsule Endoscope System | NEZ | Substantially Equivalent | CapsoVision, Inc. | accessdata.fda.gov |
| July 20, 2016 | K152189 | EVOTECH ECR | FEB | Substantially Equivalent | Advanced Sterilization Products (Asp) | accessdata.fda.gov |
| May 26, 2016 | K161228 | Radiance Ultra Series ZeroWire Embedded | GCJ | Substantially Equivalent | Nds Surgical Imaging, LLC | accessdata.fda.gov |
| May 13, 2016 | K153563 | AirFit F20 | BZD | Substantially Equivalent | Resmed, Ltd. | accessdata.fda.gov |
| April 13, 2016 | K152329 | Coldplay Cryoballoon; Focal Ablation System, Full Ablation System; Swipe Ablation System | GEH | Substantially Equivalent | C2 Therapeutics, Inc. | accessdata.fda.gov |
| January 7, 2016 | K153541 | Coldplay CryoBalloon® Ablation System | GEH | Substantially Equivalent | C2 Therapeutics, Inc. | accessdata.fda.gov |
| July 7, 2015 | K151054 | Coldplay Full CryoBalloon Ablation System and Coldplay Swipe CryoBalloon Ablation System | GEH | Substantially Equivalent | C2 Therapeutics, Inc. | accessdata.fda.gov |
| January 14, 2015 | K142368 | NOBLUS DIAGNOSTIC ULTRASOUND SCANNER | IYN | Substantially Equivalent | Hitachi Aloka Medical, Ltd. | accessdata.fda.gov |
| March 28, 2014 | K134016 | ARIETTA 70/ARIETTA S70/ARIETTA V70 DIAGNOSTIC ULTRASOUND SCANNER | IYN | Substantially Equivalent | Hitachi Aloka Medical,Ltd. (Hitachi Aloka Medical | accessdata.fda.gov |
| July 5, 2013 | K131078 | SYSTEM 1E LIQUID CHEMICAL STERILANT PROCESSING SYSTEM | MED | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| June 20, 2012 | K113310 | ENDOGATER AVANTAGE CO2 INSUFFLATOR | FCX | Substantially Equivalent | Byrne Medical, Inc. | accessdata.fda.gov |
| April 27, 2012 | K113119 | ENDOGATOR ADVANTAGE IRRIGATION PUMP | OCX | Substantially Equivalent | Byrne Medical, Inc. | accessdata.fda.gov |
| June 17, 2010 | K093466 | HI VISION PREIRUS DOAGNOSTIC ULTRASOUND SCANNER MODEL HI VISION PREIRUS | IYO | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
| March 18, 2010 | K093792 | LED LIGHT SOURCE | FCW | Substantially Equivalent | Sunoptic Technologies, LLC | accessdata.fda.gov |
| February 22, 2010 | K093718 | ZUTRON MEDICAL ENDOSCOPE LEAK TESTER MODEL ZUTR-10003 | FCY | Substantially Equivalent | Zutron Medical, LLC | accessdata.fda.gov |
| December 15, 2009 | K093665 | ENDO SMARTCAP | FAJ | Substantially Equivalent | Byrne Medical, Inc. | accessdata.fda.gov |
| November 19, 2009 | K092429 | ENDOGATOR | FEQ | Substantially Equivalent | Byrne Medical, Inc. | accessdata.fda.gov |
| June 14, 2007 | K063876 | MODULAR DISINFECTION SYSTEM (MDS) FOR ENDOSCOPE REPROCESSING | FEB | Substantially Equivalent | Medivators Reprocessing Systems | accessdata.fda.gov |
| April 19, 2006 | K060962 | ENDOGATOR ENDOSCOPY IRRIGATION PUMP, MODEL EGP-100 | OCX | Substantially Equivalent | Byrne Medical, Inc. | accessdata.fda.gov |
| December 17, 2004 | K040049 | THE RELIANCE ENDOSCOPE PROCESSING SYSTEM | NZA | Substantially Equivalent | STERIS Corporation | accessdata.fda.gov |
| August 22, 2003 | K032503 | EUB-5500 DIAGNOSTIC ULTRASOUND SCANNER | IYN | Substantially Equivalent | Hitachi Medical Systems America, Inc. | accessdata.fda.gov |
| March 11, 1999 | K990240 | ELECTROGLOTTOGRAPH | KLX | Substantially Equivalent | Kay Elemetrics Corp. | accessdata.fda.gov |
| September 22, 1998 | K983017 | MODIFICATION TO SYSTEM 83 PLUS | NVE | Substantially Equivalent | Custom Ultrasonics | accessdata.fda.gov |
| June 4, 1996 | K954798 | 7100 SWALLOWING WORKSTATION | KLA | Substantially Equivalent | Kay Elemetrics Corp. | accessdata.fda.gov |
| January 26, 1995 | K944656 | OPTUS SINUSCOPES AND ACCESSORIES | EOB | Substantially Equivalent | Optus, Inc. | accessdata.fda.gov |
| February 22, 1994 | K914145 | DSD-91(TM) DISINFECTOR FOR FLEXIBLE ENDOSCOPES | FEB | Substantially Equivalent | Medivators, Inc. | accessdata.fda.gov |
| May 28, 1992 | K921285 | 9105 RIGID TELESCOPIC ENDOSCOPE | EQL | Substantially Equivalent | Kay Elemetrics Corp. | accessdata.fda.gov |
| May 28, 1992 | K921184 | RLS 9100 RHINO-LARYNGEAL STROBOSCOPE | EQL | Substantially Equivalent | Kay Elemetrics Corp. | accessdata.fda.gov |
| December 6, 1988 | K884836 | UNIVERSAL GENERATOR IRRIGATOR MODEL UGI-3000 | GEI | Substantially Equivalent | Meditron Devices, Inc. | accessdata.fda.gov |
| January 14, 1988 | K871712 | MACHIDA AMERICA MODEL AC-5000 AUTOMATIC DISINFECT. | NVE | Substantially Equivalent | Machida America, Inc. | accessdata.fda.gov |
| October 20, 1983 | K832458 | AUTOMATIC ENDOSCOPE | NVE | Substantially Equivalent | American Endoscopy, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| September 9, 2026 | 99782 | Not yet classified | Open, Classified | PENTAX Medical Ultrasound Endoscope. Model Number. EG36-J10UR. | Warnings added to the IFU for ultrasound endoscopes and water bottle assembly to ensure there is deaerated sterile water in the assembly prior to and during the procedure. | accessdata.fda.gov |
| July 16, 2025 | 97073 | Class II | Ongoing | 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 dark. Users have observed smoke like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient and may cause thermal injury to the patient s muco | accessdata.fda.gov |
| January 29, 2025 | 96164 | Class II | Ongoing | 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 | 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 dark (1.8%). Users have observed smoke-like steam and noted that the light guide at the tip is hot during use / after the endoscope is removed from the patient, and may cause thermal injury to the pa | accessdata.fda.gov |
| July 14, 2021 | 88440 | Class II | Ongoing | 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, EC34-i10L, EC38-i10L; | Updated Reprocessing Instruction For Use (rIFU): Impacted PENTAX Medical Video Upper GI Scopes (EG) and Video Colonoscopes (EC) families | accessdata.fda.gov |
| April 21, 2021 | 87763 | Class II | Terminated | 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 access to, Biliary T | 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 risks with the distal end cap (OE-A63) unexpectedly becoming detached during a procedure and updated to notify users of what immediate actions should be taken in case the event occurs. This can result i | accessdata.fda.gov |
| September 22, 2020 | 86440 | Class II | Terminated | 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 (Patient B). This does not occur at the time the user performs and initially reviews an exam; it is not evident until a follow-up review occurs. | accessdata.fda.gov |
| January 3, 2020 | 84735 | Class II | Terminated | Pentax Video Colonoscope Model: EC34-i10L | Distributed in the USA without an approved 510K | accessdata.fda.gov |
| February 13, 2018 | 79237 | Class II | Terminated | 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 access to, the biliary t | The duodenoscopes are being recalled in order to replace the forceps elevator mechanism, the O-rings, and the distal end covering to be consistent with the updated design as well as provide an updated periodic inspection as part of the Operation Manual in order to mitigate the potential risk of infection in flexible endoscopy. | accessdata.fda.gov |
| July 13, 2017 | 79131 | Class II | Terminated | Video Cystoscope models ECY-1570 and ECY-1570K | The video cytoscopes lack 510(k) premarket notification clearance. | accessdata.fda.gov |
| May 23, 2017 | 77380 | Class II | Terminated | 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 video processor to provide i | Error in reprocessing instructions in Revisions 13 and 14 of IFU Z845, used with EG-3670URK and EG-3870UTK ultrasound gastroscopes. In the disinfection step, the IFU has a warning indicating the cleaning detergent solution should remain in contact with the all internal channels and external endoscope surfaces. The disinfecting solution, not the cleaning dete | accessdata.fda.gov |
| April 13, 2017 | 77137 | Class II | Terminated | 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 related to swallowing in the | Pentax Medical did not always provide transformers with 9175 isolation transformers are used with 7245C, 7245C/E, 7245D, 9200Cs, 9200Ds, 9310HDs, and 9400s computer systems. | accessdata.fda.gov |
| January 17, 2017 | 77308 | Class II | Terminated | 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 includes, but is not restrict | Pentax initiated a field correction/safety alert for two (2) models of the Video Duodenoscope to determine how soiling may have occurred on the surface of the suction cylinder and under the distal cap during testing. | accessdata.fda.gov |
| December 12, 2016 | 76089 | Class II | Terminated | 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 when indications con | Pentax is initiating a Field Correction to revise the Instructions for Use of the Rigid Laryngostroboscopes Model 9106 and 9108. | accessdata.fda.gov |
| August 15, 2016 | 75332 | Class II | Terminated | 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 ancillary equipment for end | PENTAX Medical is initiating this field action to provide customers that have purchased the affected endoscopes with the most recent Operation and Reprocessing IFUs. | accessdata.fda.gov |
| August 15, 2016 | 75306 | Class II | Terminated | 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 ancillary equipment for end | Pentax is initiating the product correction of several model numbers of Pentax's Colonoscope that were shipped between the clearance date of April 2014 and September 2015 because they contain the operation and reprocessing IFU's that were in use prior to the 2014 clearances and therefore did not include the cleared operation IFU, the updated reprocessing IFU | accessdata.fda.gov |
| May 31, 2016 | 75249 | Class II | Terminated | 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 Track including but not r | The EB-1970UK Ultrasound Video Bronchoscope shipped between the clearance date of April 2014 and September 2015 contained the Operation and Reprocessing IFUs that were in use prior to the 2014 clearance, and therefore did not include the cleared Operation and Reprocessing IFUs. | accessdata.fda.gov |
| May 31, 2016 | 74954 | Class II | Terminated | 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 other ancillary equipmen | Pentax America Inc. is recalling various bronchoscopes which contain an incorrect Operation and Reprocessing IFUS. | accessdata.fda.gov |
| April 6, 2016 | 73985 | Class II | Terminated | Colonoscope Product Usage: Intended to provide optical visualization of and therapeutic access to the Lower Gastrointestinal Tract. This anatomy includes, but is not restricted to, the organs; tissues; and subsystems: La | Pentax Medical Video Processor EPK-i5010 has been shipped with a reusable Pentax Medical water bottle assembly (OS-H4) which has not been cleared for use with this devices in the United States. | accessdata.fda.gov |
| April 6, 2016 | 73894 | Class II | Terminated | Bronchoscope Intended to provide optical visualization of and therapeutic access to the Airway and Bronchial Tree. This anatomy includes, but is not restricted to, the organs, tissues and subsystems: Nasal Passage, Trach | Pentax has become aware that operational/cleaning accessories and therapeutic devices (e.g., clips, stents, balloons, etc.) can become lodged in an endoscope's instrument channel. | accessdata.fda.gov |
| February 22, 2016 | 73377 | Class II | Terminated | Video Duodenoscope | Pentax Medical learned of reports of carbapenem-resistant Enterobacteriaceae (CRE) infection at a medical facility. | accessdata.fda.gov |
| July 17, 2014 | 68753 | Class II | Terminated | PENTAX Upper/Lower G.I. Endoscope OF-B130 and OF-B194 Gas/Water Feeding Valve | The Instructions for Use for the Pentax OF-B130 and OF-B194 Gas/Water Valve IFU if not followed carefully may cause a potential risk to health. | accessdata.fda.gov |
| June 12, 2014 | 68586 | Class II | Terminated | EG-3630U Ultrasound Video Gastroscope EG-3830UT Ultrasound Video Gastroscope EG-3870UTK Ultrasound Video Gastroscope FG-36UX Ultrasound Fiber Gastroscope Used to provide optical and sonographic visualization of and thera | Aspiration needles used in combination with Ultrasound Gastroscopes can derail from the accessory elevator at the distal end of the endoscope. This may result in patient injury if the Instruction for Use is not followed carefully by the user. | accessdata.fda.gov |
| September 16, 2013 | 66379 | Class I | Terminated | PENTAX Endoscopic Accessories. OF-B194. Made in Japan. PENTAX Upper/Lower G.I. Endoscopes are provided with Air/Water Valve. As an alternative, the optionally available Gas/Water Valve may be used in place of the standar | PENTAX Medical has become aware of a product issue associated with the OF-B194 Gas/Water Feeding Valve. A manufacturing defect may cause improper stoppage of CO2 gas during an endoscopic procedure with the potential for serious hazard to and/or user. | accessdata.fda.gov |
| March 14, 2012 | 61613 | Not yet classified | Terminated | EG-3870UTK, Pentax Ultrasound Video Gastroscope. The EG-3870UTK, Ultrasound Video Gastroscope, is intended to provide optical visualization via a video monitor of, ultrasonic visualization of, and therapeutic access to t | Endoscope ultrasound balloon evacuation tube may become clogged with patient body fluid if users fail to properly follow instructions for pre-procedure check, operating the suction valve during procedure and pre-cleaning procedure. | accessdata.fda.gov |
| September 30, 2011 | 60788 | Not yet classified | Terminated | EB- Series Video Bronchoscopes, EB-1570K & EB-1970K. Intended to provide optical visualization of (via a video monitor), and therapeutic access to, the Pulmonary Tract. | The wrong silicone sealant was used and excess sealant was neglected to be removed during repair of the bronchoscope. | accessdata.fda.gov |
| January 11, 2011 | 77310 | Class II | Terminated | Video Bronchoscope | This field action serves to retrospectively document the actions that were taken by Pentax to correct the loose suction arms on eleven (11) models of endoscopes and to notify FDA of these actions taken in 2010-2011. | accessdata.fda.gov |
Compare with other makers
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- All makers of Transducer, Ultrasonic, Diagnostic
- All makers of System, Imaging, Pulsed Echo, Ultrasonic
Updated October 28, 2026. 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.