# K251894: Himaging Bronchscope System

- Pathway: 510(k) (Traditional)
- Applicant: Himaging Technology (Shanghai) Co., Ltd.
- Decided: Sep 23, 2025 after 95 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.
No later device cites it as a predicate yet.
1 of 27 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 6.

## Indications for use
The sterile single-use flexible video bronchoscopes are designed to be used with the Himaging endoscopic video processor, monitor, endotherapy accessories and other ancillary equipment for endoscopy within the airways and tracheobronchial tree. The Himaging bronchoscope system is applicable to hospital environment or medical office environment. The Himaging bronchoscopes are sterile single-use devices designed for use in adults.

Source page: https://510kreport.com/device/K251894
Methodology: https://510kreport.com/methodology