# K130067: Mrna Appliance

- Pathway: 510(k) (Abbreviated)
- Applicant: Biomodeling Solutions, Lls
- Decided: May 8, 2014 after 483 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: 9 generations back to K882303 (1989). 17 ancestors in all.
5 later devices descend from it; 3 cite it directly.
0 of 23 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050592: Somnomed Mas Rxa, Somnomed, Ltd. (2005) Summary page 2.
- K103076: Dynaflex, Dyna Flex (2011) Summary page 1.
- K130130: Atg/SM-Osa Appliances, Selane Products, Inc. (2013). Cleared while this submission was under review Summary page 1.

## Most influential descendants
- K222872: DNA Appliance (2022), 2 descendants of its own
- K230947: C.A.R.E. Appliance (DNA, mRNA, mmRNA) (2023), 1 descendant of its own
- K234089: DNA Appliance (2024), 0 descendants of its own
- K210203: mmRNA appliance (2021), 0 descendants of its own
- K181123: ApnoDent Appliance (2018), 0 descendants of its own

## Indications for use
For the treatment of snoring and mild to moderate obstructive sleep apnea in adults.

Source page: https://510kreport.com/device/K130067
Methodology: https://510kreport.com/methodology