# K140663: Therasnore

- Pathway: 510(k) (Abbreviated)
- Applicant: Distar, LLC
- Decided: Dec 12, 2014 after 269 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: 5 generations back to K882303 (1989). 13 ancestors in all.
No later device cites it as a predicate yet.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113022: Puresleep, Sleep Science Partners, Inc. (2012) Summary page 6.
- K973038: Adjustable Therasnore, Distar, Inc. (1997) Summary page 6.

## Indications for use
Adjustable TheraSnore appliance is indicated for the treatment of snoring and mild to moderate obstructive sleep apnea in patients 18 years of age or older.

Source page: https://510kreport.com/device/K140663
Methodology: https://510kreport.com/methodology