Cleared Abbreviated

SNIFF POSITION PILLOWS/POPITZ PILLOWS (K023010) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through the Abbreviated 510(k) pathway - typically does not require clinical trials.

K023010 · Aeolus International Corporation · Ear, Nose, Throat device
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Oct 2002
Decision
22d
Days
Class 2
Risk

K023010 is an FDA 510(k) clearance for the SNIFF POSITION PILLOWS/POPITZ PILLOWS. Classified as Pillow, Cervical (for Mild Sleep Apnea) (product code MYB), Class II - Special Controls.

Submitted by Aeolus International Corporation (Marion, US). The FDA issued a Cleared decision on October 1, 2002 after a review of 22 days - a notably fast clearance cycle.

This device falls under the Ear, Nose, Throat FDA review panel, regulated under 21 CFR 872.5570 - the FDA ear, nose and throat device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Aeolus International Corporation devices

Submission Details

510(k) Number K023010 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 09, 2002
Decision Date October 01, 2002
Days to Decision 22 days
Submission Type Abbreviated
Review Panel Ear, Nose, Throat (EN)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
67d faster than avg
Panel avg: 89d · This submission: 22d
Pathway characteristics
Standards-based clearance path.

Device Classification

Product Code MYB Pillow, Cervical (for Mild Sleep Apnea)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 872.5570
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Ear, Nose, Throat devices follow this clearance model.