# K202180: Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001

- Pathway: 510(k) (Traditional)
- Applicant: Axess Vision Technology
- Decided: Oct 22, 2020 after 79 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.
1 later device descends from it; 1 cites it directly.
1 of 28 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 5.

## Most influential descendants
- K212886: Broncoflex Agile, Broncoflex Vortex, Screeni (2022), 0 descendants of its own

## Indications for use
Broncoflex Agile and Vortex This video-bronchoscope is intended to provide an optical display of the pulmonary tract using a monitor (Screeni®) and to be used with endotherapy accessories and instruments. This video-bronchoscope is designed for use exclusively in a hospital environment. Endotherapy accessories and instruments The effective length of an endoscopic instrument should be at least 30 cm greater than the effective length of the endoscope. Model Minimum compatible Minimum compatible dual lumen Maximum size of endotherapy instruments endotracheal tube size endo-bronchial tube size Broncoflex Agile Broncoflex Vortex Patient Population The Broncoflex can only be used in adult patients Screeni This device is designed for use exclusively in a hospital environment, in combination with an Axess Vision Broncoflex video-bronchoscope.

Source page: https://510kreport.com/device/K202180
Methodology: https://510kreport.com/methodology