# K242416: Single-use Flexible Bronchoscope: BC-E1C10, BC-E1C11, BC-E1C12, BC-E1E10, BC-E1E11, BC-E1E12, BC-E1H10, BC-E1H11, BC-E1H12; Digital Video Monitor: DVM-D1, DVM-D2; Single-use sampler: S-20mL, S-30mL, S-50mL

- Pathway: 510(k) (Traditional)
- Applicant: Hunan Vathin Medical Instrument Co., Ltd.
- Decided: Jan 16, 2025 after 154 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). 42 ancestors in all.
No later device cites it as a predicate yet.
2 of 43 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K210883: aScope 4 Broncho Regular Sampler Set 5.0/2.2, aScope 4 Broncho Large Sampler Set 5.8/2.8, Ambu A/S (2021) Summary page 6.
- K223299: Ambu® aScope™ 5 Broncho HD 5.0/2.2, Ambu® aScope™ 5 Broncho HD 5.6/2.8, Ambu® aView™ 2 Advance, Ambu A/S (2023) Summary page 6.

## Indications for use
The Single-use Flexible Bronchoscope has been designed to be used with Vathin Display Units, endoscopic accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. Single-use Sampler is designed as an add-on for use during Bronchial Alveolar Lavage (BAL) or Bronchial Wash (BW) procedures which enable aspiration and collection of fluid sample(s) from the bronchial or alveolar part of the lung. The Digital Video Monitor is specially designed to be used with Vathin medical endoscopes and other auxiliary equipment for the purposes of endoscopic diagnosis, treatment and video observation. The Video Bronchoscope System is for use in professional Healthcare Facility Environment.

Source page: https://510kreport.com/device/K242416
Methodology: https://510kreport.com/methodology