# K133390: NDX Dorsal Appliance

- Pathway: 510(k) (Traditional)
- Applicant: Institute For Quality Resource Management
- Decided: Oct 16, 2014 after 345 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). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 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 4.

## Indications for use
The ClearDream® is intended to reduce night time snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K133390
Methodology: https://510kreport.com/methodology