# K181546: Dillard Nasal Balloon Catheter

- Pathway: 510(k) (Traditional)
- Applicant: Intuit Medical Products, LLC
- Decided: Jan 3, 2020 after 570 days
- Product code: LRC (Instrument, Ent Manual Surgical)
- Device class: 1
- Regulation: 21 CFR 874.4420
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K183090 (2019). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183090: Relieva Tract Balloon Dilation System, Acclarent, Inc. (2019). Cleared while this submission was under review Summary page 4.

## Indications for use
The Dillard Nasal Balloon (DNB) Catheter is an instrument intended to provide increased intranasal space to facilitate access for endonasal and transnasal procedures and/or temporarily address nasal obstruction by displacing the inferior turbinate and lower nasal septum. The Dillard Nasal Balloon (DNB) Catheter is intended for use in ages 17 years or older.

Source page: https://510kreport.com/device/K181546
Methodology: https://510kreport.com/methodology