# K243541: LumiRex Bronchoscope

- Pathway: 510(k) (Traditional)
- Applicant: Contra Healthcare Solutions, LLC
- Decided: Apr 30, 2025 after 166 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.
No later device cites it as a predicate yet.
1 of 28 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K191828: Vathin Video Bronchoscope System, Hunan Vathin Medical Instrument Co., Ltd. (2020) Summary page 5.

## Indications for use
The LumiRex Bronchoscope is a single-use flexible endoscope designed to be used with Contra Healthcare Solutions video processors, endotherapy accessories, and ancillary equipment for endoscopy and endoscopic procedures within the airways and the tracheobronchial tree in a hospital environment.

Source page: https://510kreport.com/device/K243541
Methodology: https://510kreport.com/methodology