# K121285: Oravan Osa

- Pathway: 510(k) (Traditional)
- Applicant: New Jersey Snoring Solutions
- Decided: Mar 8, 2013 after 312 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: 4 generations back to K882303 (1989). 6 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 9 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.
- K093710: The Moses Appliance, Allen J. Moses, Dds, Ltd. (2010) Summary page 2.

## Most influential descendants
- K152159: Oravan Herbst (2015), 0 descendants of its own
- K130797: Luco Hybrid Osa Appliance (2013), 0 descendants of its own

## Indications for use
Oravan OSA is intended to reduce snoring and mild to moderate sleep apnea in adults

Source page: https://510kreport.com/device/K121285
Methodology: https://510kreport.com/methodology