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PENTAX of America, Inc.

USA · Montvale

✓ Record-verifiedregistrations found in 8 markets

This company has registrations in United States, Saudi Arabia, Canada, Taiwan, Singapore, South Korea, Australia, Israel — 8 overseas markets. The China NMPA lookup is still pending.

Registrations by market

Each market counts a different unit; figures are not directly comparable

CNChinaNMPA

n/aThis registry lists domestic registrants only

EUEuropean UnionEUDAMED

pendingnot queried

USUnited StatesFDA openFDA

36listed device types

Class I 12Class II 24Class III 0

plus 51 registration records and 48 510(k)

UKUnited KingdomMHRA PARD

pendingnot queried

BRBrazilANVISA

0registered devices

this export covers Class I / II only (the cadastro route)

SASaudi ArabiaSFDA

20registered imported devices

low-risk imported devices only; a 2023 snapshot, not updated since

CACanadaMDALL

3active device licences

Class II 3

23 including historic records

TWTaiwanTFDA

4valid device licences

Class I 4

SGSingaporeHSA SMDR

1device registrations

CLASS B 1

KRSouth KoreaMFDS GMP

1GMP quality-system certificates

Import 1

AUAustraliaTGA ARTG

3active ARTG entries

Class I 3

HKHong KongMDACS

pendingnot queried

ILIsraelAMAR

1registrations

RURussiaRoszdravnadzor

pendingnot queried

Not yet connected: India CDSCO, Indonesia Kemenkes. The public search for Japan PMDA and Vietnam IMDA does not return manufacturer names, so entries cannot be linked to companies coming — where there is no data it is shown as "pending", never estimated.

How these numbers were verified

record-verified

Company-name search in every official database is a substring match and returns same-named but different companies. Each figure below is the count after re-checking every record against the manufacturer name.

United States51 registration records, 48 510(k), 0 PMA, 8 excluded

Brazil0 confirmed, 2 excluded

Saudi Arabia20 confirmed, 0 excluded

Canada3 confirmed, 3 excluded

Manufacturer names merged into this page: PENTAX of America, Inc. · PENTAX OF AMERICA, INC. · PENTAX MEDICAL, A DIVISION OF PENTAX OF AMERICA, INC · Pentax of America, Inc · PENTAX MEDICAL COMPANY, a Division of PENTAX of America, Inc

FDA 510(k) clearances by year

12012

22013

22015

22017

62018

112019

42020

72021

32022

22023

52024

32025

FDA listed device types

showing 8 of 36

Electrosurgical, Cutting & Coagulation & Accessories 1Cystoscope And Accessories, Flexible/Rigid 1Accessories, Cleaning, For Endoscope 1Accessories, Germicide, Cleaning, For Endoscopes 1Endoscopic Leak Tester 1Insufflator, Automatic Carbon-Dioxide For Endoscope 1Laparoscope, General & Plastic Surgery 1Endoscope Channel Accessory 1

Registration details (sample)

Market	Identifier	Name	Class / date
US	K251256	PENTAX Medical Video Upper GI Scopes (EG Family) (EG Family); PENTAX Medical Video Colonoscopes (EC Family) (EC Family)	2025-12-16
US	K251127	PENTAX Medical Video Processor (EPK-i8020c)	2025-06-03
US	K242110	PENTAX Medical Video Colonoscope (EC38-i20cWL)	2025-01-03
SA	ME0000000390SFDAA00002	Digital Capture	—
SA	ME0000000390SFDAA00001	LARYNGEAL STROBE	—
CA	89495	AMBULATORY PHONATION MONITOR	Class II
CA	90536	ELECTROGLOTTOGRAPH	Class II
CA	90541	KAYPENTAX DIGITAL SWALLOWING WORKSTATION	Class II

PENTAX of America, Inc.

Registrations by market

How these numbers were verified

Company information

FDA 510(k) clearances by year

FDA listed device types

Registration details (sample)

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