# K252858: 4K UHD Endoscopy Camera System (KMS-4K-2088, KMS-4K-2188, KMS-4K-2288)

- Pathway: 510(k) (Traditional)
- Applicant: Kms Medical Technology Co., Ltd.
- Decided: Apr 30, 2026 after 233 days
- Product code: GCJ (Laparoscope, General & Plastic Surgery)
- Device class: 2
- Regulation: 21 CFR 876.1500
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K950862 (1995). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K180583: Logic 4K Camera Controller, Logic 4K Camera Head, Richard Wolf Medical Instruments Corporation (2018) Summary page 5.

## Indications for use
The 4K UHD Endoscopy Camera System, when used in conjunction with optical endoscope, cold light source and monitor, is intended to convert the optical signals captured by the endoscope into electronic signals and transmits them to the monitor for imaging, and can be used for both diagnostic and therapeutic interventions.

Source page: https://510kreport.com/device/K252858
Methodology: https://510kreport.com/methodology