# K234089: DNA Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Vivos Therapeutics
- Decided: Sep 16, 2024 after 269 days
- 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: 12 generations back to K882303 (1989). 20 ancestors in all.
No later device cites it as a predicate yet.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K230947: C.A.R.E. Appliance (DNA, mRNA, mmRNA), Vivos Therapeutics, Inc. (2023) Summary page 6.

## Indications for use
The DNA Appliance is intended to reduce nighttime snoring and to treat moderate and severe obstructive sleep apnea in children, 6- 17 years of age who are diagnosed with snoring and/or moderate or severe obstructive sleep apnea and need orthodontic treatment.

Source page: https://510kreport.com/device/K234089
Methodology: https://510kreport.com/methodology