# K250232: Vathin® Video Bronchoscope System

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Decided: Jul 25, 2025 after 179 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: 13 generations back to K921244 (1992). 30 ancestors in all.
No later device cites it as a predicate yet.
1 of 31 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K223836: Vathin® Video Bronchoscope System, Hunan Vathin Medical Instrument Co., Ltd. (2023) Summary page 5.
- K211947: GlideScope BFlex 2.8 Single-Use Bronchoscope, Verathon Medical (Canada) Ulc (2021) Summary page 5.
- K230948: BFlex™ 2 Slim 3.8 Single-Use Bronchoscope, Verathon Medical (Canada) Ulc (2023) Summary page 5.

## Indications for use
The Vathin®H-SteriScopeTM single-use flexible video bronchoscope has been designed to be used with the Vathin display unit, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree in patients. The Vathin® Video Bronchoscope System is for use in a hospital environment. The Vathin®H-SteriScopeTM single-use flexible video bronchoscope is a single-use device designed for use in adults, with the BCV1-02 and BCV1-C2 also designed for pediatric use (BCV1- 02: 6 months to 6 years; BCV1-C2: 6 years and older).

Source page: https://510kreport.com/device/K250232
Methodology: https://510kreport.com/methodology