# K231107: Bronchoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Endoso Life Technology Co., Ltd.
- Decided: Feb 15, 2024 after 302 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: 11 generations back to K921244 (1992). 27 ancestors in all.
1 later device descends from it; 1 cites it directly.
1 of 29 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191828: Vathin Video Bronchoscope System, Hunan Vathin Medical Instrument Co., Ltd. (2020) Summary page 5.

## Most influential descendants
- 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) (2025), 0 descendants of its own

## Indications for use
The Single-use Bronchoscopes have been designed to be used with the Monitor for Single-Use Endoscopy, 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 disposable device designed for use in adults.

Source page: https://510kreport.com/device/K231107
Methodology: https://510kreport.com/methodology