# K230947: C.A.R.E. Appliance (DNA, mRNA, mmRNA)

- Pathway: 510(k) (Traditional)
- Applicant: Vivos Therapeutics, Inc.
- Decided: Nov 28, 2023 after 238 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: 11 generations back to K882303 (1989). 19 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222872: DNA Appliance, Vivos Therapeutics, Inc. (2022) Summary page 5.

## Most influential descendants
- K234089: DNA Appliance (2024), 0 descendants of its own

## Indications for use
The C.A.R.E. Appliances are intended to reduce nighttime snoring and to treat mild and moderate obstructive sleep apnea in adults, 18 years of age and older. The C.A.R.E. Appliances are also intended to treat moderate and severe obstructive sleep apnea (OSA) in adults, 18 years of age and older along with positive airway pressure (PAP) devices and/or myofunctional therapy, as needed.

Source page: https://510kreport.com/device/K230947
Methodology: https://510kreport.com/methodology