# K153484: Dillard Airway Dilatation System

- Pathway: 510(k) (Traditional)
- Applicant: Intuit Medical Products, LLC
- Decided: Jul 27, 2016 after 237 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: 4 generations back to K043527 (2005). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090660: Airway Balloon Catheter Inflation Device, Acclarent, Inc. (2009) Summary page 4.

## Indications for use
The Dillard Airway Dilatation System is intended to dilate strictures of the airway trees.

Source page: https://510kreport.com/device/K153484
Methodology: https://510kreport.com/methodology