# K130504: Asa Oral Appliances

- Pathway: 510(k) (Traditional)
- Applicant: American Sleep Association
- Decided: Oct 18, 2013 after 233 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: 1 generation back to K972424 (1997). 3 ancestors in all.
2 later devices descend 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)
- K070327: Removable Arylic Herbst, Allesee Snore Appliance (Asa), and Enoch Snorinator, Sybron Dental Specialties, Inc. (2007) Summary page 1.
- K963591: Snoring Control Device, Kenneth Hilsen (1998) Summary page 1.
- K972424: Silentnite, Glidewell Laboratories (1997) Summary page 1.

## Most influential descendants
- K163580: ASD Oral Appliances (2017), 1 descendant of its own
- K190353: Bfit Sleep, Bfit Sleep with DentiTrac, Bfit Engage, Bfit Engage with DentiTrac (2020), 0 descendants of its own

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

Source page: https://510kreport.com/device/K130504
Methodology: https://510kreport.com/methodology