# K240283: BubbleView™ Single-Use Digital Flexible Cystoscope (C50-C, C50-CR, C50-CB, C50-CBR); ViewHub® Video Processor (S13, S13-T, S13-N, S13-S)

- Pathway: 510(k) (Traditional)
- Applicant: MacroLux Medical Technology Co., Ltd.
- Decided: Jun 10, 2024 after 130 days
- Product code: FAJ (Cystoscope And Accessories, Flexible/Rigid)
- 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: 11 generations back to K921244 (1992). 45 ancestors in all.
No later device cites it as a predicate yet.
2 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222602: Pusen Single Use Flexible Video Cystoscope System (Single Use Flexible Video Cystoscope: PC200-AS, PC200-AR, PC200-S and PC200-R; HD Medical Video Endoscope Image Processor: PV300), Zhuhai Pusen Medical Technology Co., Ltd. (2022) Summary page 5.

## Indications for use
The BubbleView TM Single-Use Digital Flexible Cystoscope is a sterile, single-use, flexible endoscope intended to be used for endoscopic access to and examination of the lower urinary tract. The BubbleViewTM is intended to provide visualization via ViewHub@ video processor and can be used with endoscopic accessories. BubbleViewTM is intended for use in a hospital environment or medical office environment. BubbleView TM is designed for use in adults. ViewHub@ is designed to display live imaging data from compatible MACROLUXr endoscopes.

Source page: https://510kreport.com/device/K240283
Methodology: https://510kreport.com/methodology