# K250462: UL UHD-Clear View 4K Camera System (UL-3Chip 4K)

- Pathway: 510(k) (Traditional)
- Applicant: Univlabs Technologies Private Limited
- Decided: Aug 11, 2025 after 174 days
- Product code: FET (Endoscopic Video Imaging System/Component, Gastroenterology-Urology)
- 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: 5 generations back to K944620 (1995). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K201135: Image1 S CCU, Image1 S 4U Camera Head, KARL STORZ Endoscopy-America, Inc. (2020) Summary page 5.

## Indications for use
The UL UHD-Clear View 4K Camera System (UL-3Chip 4K), consisting of a Camera Control Unit and an Endoscopic Camera Head, is indicated for use with compatible endoscopes to provide visualization during general endoscopic procedures. These procedures may involve the visual inspection of internal anatomical structures to support diagnostic or therapeutic interventions. Patient suitability for particular endoscopic procedures must be determined by the responsible physician based on the individual’s clinical condition.

Source page: https://510kreport.com/device/K250462
Methodology: https://510kreport.com/methodology