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4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)

by KMS Medical Technology Co., Ltd

510(k) K252858Ref KMS4KModel KMS-4K-2088, KMS-4K-2188, KMS-4K-2288

Active European Union and United States

CE MDR 510(k)

Valid until

Not listed

CE: no date in EUDAMED. FDA: not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

None linked in EUDAMED

A group certificate may exist

510(k) K252858↗

FDA record

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source EUDAMED, FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE 510(k) Substantially Equivalent · Traditional NumberK252858 Date30 Apr 2026ClearedStatusActive
European UnionCE/MDR EUDAMED Number697639493KMS4KCAMPM Basic UDI-DI 16976394931170UDI-DIDate2 Apr 2026RegisteredStatusActive

Certificates

0 certificates · EUDAMED

EUDAMED lists no certificate for this device's Basic UDI-DI.

A certificate issued for a device group may exist without being linked here.

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

2 jurisdictions

United States of AmericaSwedenFinlandLatviaEstoniaDenmarkLithuaniaIrelandNetherlandsGermanyPolandFranceBelgiumLuxembourgCzech RepublicSlovakiaAustriaHungaryRomaniaSloveniaBulgariaPortugalSpainItalyCroatiaGreeceMaltaCyprus
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered
  • European Union CE/MDR Active
  • United States FDA 510(k) Active

Specification

EUDAMED · 510(k)

Trade Name
4K UHD Endoscopy Camera System
Model / Reference
KMS-4K-2088, KMS-4K-2188, KMS-4K-2288, KMS4K
FDA applicant
Kms Medical Technology Co., Ltd.
Primary DI / UDI-DI
16976394931170
Basic UDI-DI
697639493KMS4KCAMPM
Direct Marketing DI
16976394931170
510(k) Number
FDA Product Code
GCJ
EMDN Code
Z12020401 Integrated systems for the acquisition and management of endoscopic and minimally invasive surgery images
Device Class
Class I EUDAMED
Class II 510(k)
Regulation
21 CFR Part 876.1500
EU market of registration
Portugal
Advisory Committee
Gastroenterology, Urology
FDA Decision
SESE Substantially Equivalent

Truth per registry

2 sources · 1 field differs

FieldEUDAMED510(k)
Device ClassEUDAMED
Class I
510(k)
Class II

Overview

AI-generated summary, 18 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288) is a high-resolution imaging device designed for endoscopic procedures. It captures optical signals from an endoscope, converts them into electronic signals via a CMOS image sensor in the camera head, and transmits 4K Ultra High Definition (3840x2160) video for real-time visualization.

The system is intended for use in professional healthcare settings by trained medical personnel. It includes a Camera Control Unit (CCU) for processing, recording, and outputting video via DVI, 3G-SDI, or HDMI interfaces. The device holds FDA 510(k) clearance and MDR authorization, classified under product code GCJ for general and plastic surgery applications.

Properties

Other properties (13)

  • Sterile: No
  • Implantable: No
  • Reusable: No
  • Contains Latex: No
  • Reprocessed: No
  • CMR Substance: No
  • Human-derived: No
  • Human Tissues: No
  • Animal Tissues: No
  • Endocrine Disruptor: No
  • Administering Medicine: No
  • Measuring Function: No
  • Incorporates Medicinal Product: No