# K240427: airVata™

- Pathway: 510(k) (Traditional)
- Applicant: Gelb Practice Solutions, Inc.
- Decided: Feb 14, 2024 after 1 day
- Product code: LRK (Device, Anti-Snoring)
- Device class: 2
- Regulation: 21 CFR 872.5570
- 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 K070327 (2007). 4 ancestors in all.
No later device cites it as a predicate yet.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K211069: EndSnorZ Sleep Appliance, Prismatik Dentalcraft, Inc. (2021) Summary page 4.

## Indications for use
The airVata™ sleep appliance is indicated to reduce snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older. The airVata™ sleep appliance is worn while sleeping to support the lower jaw in a forward position prescribed by the dentist. The appliance is removable by the patient.

Source page: https://510kreport.com/device/K240427
Methodology: https://510kreport.com/methodology