# K254037: LungFlow Airway Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Free Flow Medical, Inc.
- Decided: Jul 10, 2026 after 206 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: 2 generations back to K931154 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
1 of 3 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K060243: Olympus Guide Sheath, Model XBO1-836-13, Olympus Medical Systems Corporation (2006) Summary page 5.

## Indications for use
The LungFlow Airway Catheter has been designed to be used with bronchoscopes, endo-therapy accessories and ultrasound probe to guide the endo-therapy accessories or ultrasonic probe to the targeted area within the respiratory organs.

Source page: https://510kreport.com/device/K254037
Methodology: https://510kreport.com/methodology