# K013687: Nose Breathe Mouthpiece for Heavy Snorer

- Pathway: 510(k) (Traditional)
- Applicant: Steven K. Sue
- Decided: May 28, 2002 after 202 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
No predicates in its family tree.
3 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Perlis Device: named in the summary without a submission number
- (no number) Samelson Device: named in the summary without a submission number
- (no number) Grady Device: named in the summary without a submission number

## Most influential descendants
- K081965: Mpowrx Snoring Solution (2008), 2 descendants of its own
- K172991: Advanced Dental Applicance (2018), 1 descendant of its own
- K203462: Advanced Dental Appliance (2021), 0 descendants of its own

## Indications for use
It is a prescription device intended to reduce snorinc'g.

Source page: https://510kreport.com/device/K013687
Methodology: https://510kreport.com/methodology