# K242010: Bronchoscope System, The Single-use Bronchoscope (Single-use Bronchoscope: SP-Y-ZQGJ2.8, SP-Y-ZQGJ3.8, SP-Y-ZQGJ4.2, SP-Y-ZQGJ4.8, SP-Y-ZQGJ5.2, SP-Y-ZQGJ5.8; Electronic Endoscope Imaging Processor: SP-TXCLQ12.1)

- Pathway: 510(k) (Traditional)
- Applicant: Shenzhen Sanping Image Technology Co., Ltd.
- Decided: Mar 14, 2025 after 247 days
- Product code: EOQ (Bronchoscope (Flexible Or Rigid))
- Device class: 2
- Regulation: 21 CFR 874.4680
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 12 generations back to K921244 (1992). 28 ancestors in all.
No later device cites it as a predicate yet.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K231107: Bronchoscope System, Hunan Endoso Life Technology Co., Ltd. (2024) Summary page 6.
- K191828: Vathin Video Bronchoscope System, Hunan Vathin Medical Instrument Co., Ltd. (2020) Summary page 6.

## Indications for use
The Single-use Bronchoscopes have been designed to be used with the Electronic Endoscope Imaging Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Bronchoscope System is for use in a hospital environment. The Single-use Bronchoscope is a single-use device designed for use in adults.

Source page: https://510kreport.com/device/K242010
Methodology: https://510kreport.com/methodology