# K212886: Broncoflex Agile, Broncoflex Vortex, Screeni

- Pathway: 510(k) (Traditional)
- Applicant: Axess Vision Technology
- Decided: Feb 16, 2022 after 159 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)
- K202180: Broncoflex Agile; Product Reference: 20030001 , Broncoflex Vortex; Product Reference: 10030001, Screeni; Product Reference: 30030001, Axess Vision Technology (2020) Summary page 5.

## Indications for use
This video-bronchoscope is intended to prove an optical display of 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. Patient Population The Broncoflex can only be used on adult patients. 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/K212886
Methodology: https://510kreport.com/methodology