# K181219: OptiPillows EPAP Mask

- Pathway: 510(k) (Traditional)
- Applicant: Cpapnea Medical Supply
- Decided: Aug 3, 2018 after 88 days
- Product code: LWF (Dilator, Nasal)
- Device class: 1
- Regulation: 21 CFR 874.3900
- 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 K120665 (2012). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K120665: Invent Snoring Device, Ventus Medical, Inc. (2012) Summary page 4.
- (no number) Theravent: named in the summary without a submission number

## Indications for use
OptiPillows EPAP Mask is intended for use during sleep to alleviate snoring. It is intended for the adult population with snoring only.

Source page: https://510kreport.com/device/K181219
Methodology: https://510kreport.com/methodology