# K181396: Oral Device OA, Oral Device S

- Pathway: 510(k) (Traditional)
- Applicant: Passion For Life Healthcare (Uk) Limited
- Decided: Nov 16, 2018 after 171 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 K071404 (2007). 15 ancestors in all.
No later device cites it as a predicate yet.
0 of 16 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K113569: Apnearx, Apnea Science Corporation (2012) Summary page 5.
- K170825: SnoreRx, Apnea Sciences Corporation (2017) Summary page 5.

## Indications for use
The Oral Device-OA is intended to reduce night-time snoring and / or mild to moderate obstructive sleep apnea (OSA) for adults 18 and older. The Oral Device-S is intended to reduce night time snoring for adults 18 and older.

Source page: https://510kreport.com/device/K181396
Methodology: https://510kreport.com/methodology