# K202499: Diamond Digital Sleep Orthotic (DDSO)

- Pathway: 510(k) (Traditional)
- Applicant: Diamond Orthotic Laboratory
- Decided: Sep 3, 2020 after 3 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: 6 generations back to K882303 (1989). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K143244: The Panthera Anti-Snoring Device, Panthera Dental, Inc. (2014) Summary page 4.

## Indications for use
The Diamond Digital Sleep Orthotic (DDSO) is intended to reduce or alleviate snoring and mild to moderate obstructive sleep apnea (OSA) in adults.

Source page: https://510kreport.com/device/K202499
Methodology: https://510kreport.com/methodology