# K243497: Portable Video Processor (EA101), Flexible Bronchoscope BS41H-12EU, BS41H-12US, BS46H-17EU, BS50H-20EU, BS46H-17US, BS50H-20US, BS53H-22EU, BS53H-22US, BS55H-24EU, BS55H-24US, BS59H-28EU, BS59H-28US

- Pathway: 510(k) (Traditional)
- Applicant: Shanghai AnQing Medical Instrument Co., Ltd.
- Decided: May 29, 2025 after 198 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)
- K211169: Bronchoscope System, Shanghai AnQing Medical Instrument Co., Ltd. (2021) Summary page 5.

## Most influential descendants
- K251752: Flexible Bronchoscope (BS27U-12EU, BS27U-12US, BS38U-20EU, BS38U-20US) (2025), 0 descendants of its own

## Indications for use
The Flexible Bronchoscopes have been designed to be used with the video processor, 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 Flexible Bronchoscope is a single-use device designed for use in adults.

Source page: https://510kreport.com/device/K243497
Methodology: https://510kreport.com/methodology