# K254040: LungFlow Basket Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Free Flow Medical, Inc.
- Decided: Mar 12, 2026 after 86 days
- Product code: KTI (Bronchoscope Accessory)
- 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 K962367 (1996). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K020765: Microvasive Zero Tip Airway Retrieval Basket, Models M00513200 and M00513210, Boston Scientific Corp (2002) Summary page 4.

## Indications for use
The LungFlow Basket Catheter is intended to be used to endoscopically remove foreign bodies from the airway.

Source page: https://510kreport.com/device/K254040
Methodology: https://510kreport.com/methodology