Cleared Traditional

K181219 - OptiPillows EPAP Mask (FDA 510(k) Clearance)

Class I Ear, Nose, Throat device.

K181219 · Cpapnea Medical Supply · Ear, Nose, Throat device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2018
Decision
88d
Days
Class 1
Risk

K181219 is an FDA 510(k) clearance for the OptiPillows EPAP Mask. Classified as Dilator, Nasal (product code LWF), Class I - General Controls.

Submitted by Cpapnea Medical Supply (Phoenix, US). The FDA issued a Cleared decision on August 3, 2018 after a review of 88 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 874.3900 - the FDA ear, nose and throat device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Cpapnea Medical Supply devices

Submission Details

510(k) Number K181219 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 07, 2018
Decision Date August 03, 2018
Days to Decision 88 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
1d faster than avg
Panel avg: 89d · This submission: 88d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LWF Dilator, Nasal
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 874.3900
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.