# K982929: Maxair Nasal Dilator System

- Pathway: 510(k) (Traditional)
- Applicant: Hnl Technologies
- Decided: Sep 9, 1998 after 20 days
- Product code: LWF (Dilator, Nasal)
- Device class: 1
- Regulation: 21 CFR 874.3900
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The MaxAir™ Nasal Dilator is intended to be used to enhance the flow of air through the nose. The nasal dilator is designed to pull on the outer lateral wall of the nasal passage which in tumn will reduce the resistance to air flow through the nasal passage during breathinléf*The MaxAir™ Nasal Dilator's uses include, but are not limited to persons with temporary symptoms of nasal congestion which may be caused by colds, deviated septums, allergic rhinitis, and alar and valve insufficiency. The reduction of resistance to air flow in the nasal passage can also reduce the onset of snoring due to restrictions to air flow through the nasal passages.

Source page: https://510kreport.com/device/K982929
Methodology: https://510kreport.com/methodology