# K261637: Single-use Flexible Bronchoscope

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Decided: Sep 23, 2026 after 128 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). 29 ancestors in all.
No later device cites it as a predicate yet.
1 of 30 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230948: BFlex™ 2 Slim 3.8 Single-Use Bronchoscope, Verathon Medical (Canada) Ulc (2023) Summary page 6.

## Indications for use
The Single-use Flexible Bronchoscope is designed for use with Vathin Display Units. It is used for airway and bronchus examination, diagnosis and treatment.

Source page: https://510kreport.com/device/K261637
Methodology: https://510kreport.com/methodology