# K163580: ASD Oral Appliances

- Pathway: 510(k) (Traditional)
- Applicant: American Sleep Dentistry
- Decided: Jun 8, 2017 after 170 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: 2 generations back to K972424 (1997). 4 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130504: Asa Oral Appliances, American Sleep Association (2013) Summary page 4.

## Most influential descendants
- K190353: Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (2020), 0 descendants of its own

## Indications for use
The ASD Oral Appliances are intended for the reduction of night time snoring and mild to moderate obstructive sleep apnea (OSA) in individuals 18 years of age or older.

Source page: https://510kreport.com/device/K163580
Methodology: https://510kreport.com/methodology