# K191828: Vathin Video Bronchoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Decided: Feb 13, 2020 after 220 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: 10 generations back to K921244 (1992). 26 ancestors in all.
8 later devices descend from it; 5 cite it directly.
1 of 35 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173727: Ambu aScope 3 Slim 3.8/1.2 and Ambu aScope 4 Broncho Slim 3.8/1.2; Ambu aScope 3 Regular 5.0/2.2 and Ambu aScope 4 Broncho Regular 5.0/2.2; Ambu aScope 3 Large 5.8/2.8 and Ambu aScope 4 Broncho Large 5.8/2.8; Ambu aView Monitor, Ambu A/S (2018) Summary page 5.

## Most influential descendants
- K210379: Broncho Videoscope System (2021), 3 descendants of its own
- K231107: Bronchoscope System (2024), 1 descendant of its own
- K231521: Broncho Videoscope System (2023), 1 descendant of its own
- K243541: LumiRex Bronchoscope (2025), 0 descendants of its own
- K250210: Broncho Videoscope System  (Single-use Broncho Videoscope (SBV-1A-B, SBV-1A-P, SBV-1B-B, SBV-1B-P, SBV-1C-B, SBV-1C-P); Full HD Visualization Endoscopic Image Processor (HDVS-S300A, HDVS-S300B, HDVS-S300C, HDVS-S300D); Endoscopic Image Processor (HDVS-S100A, HDVS-S100D)) (2025), 0 descendants of its own

## Indications for use
The Vathin®H-SteriScopeTM I Single-use flexible Video Bronchoscope have been designed to be used with the Vathin®VisionCenterTM I Digital Video Processor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Vathin® Video Bronchoscope System is for use in a hospital environment.

Source page: https://510kreport.com/device/K191828
Methodology: https://510kreport.com/methodology