Cleared Traditional

ZZOMA POSITIONAL SLEEPER MODEL 001 (K100160) - FDA 510(k) Clearance

Class II Ear, Nose, Throat device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K100160 · Sleep Specialists, LLC · Ear, Nose, Throat device
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May 2010
Decision
111d
Days
Class 2
Risk

K100160 is an FDA 510(k) clearance for the ZZOMA POSITIONAL SLEEPER MODEL 001. Classified as Pillow, Cervical (for Mild Sleep Apnea) (product code MYB), Class II - Special Controls.

Submitted by Sleep Specialists, LLC (Greenville, US). The FDA issued a Cleared decision on May 11, 2010 after a review of 111 days - within the typical 510(k) review window.

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 Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Ear, Nose, Throat review framework, consistent with the majority of Class II 510(k) submissions.

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Submission Details

510(k) Number K100160 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2010
Decision Date May 11, 2010
Days to Decision 111 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
22d slower than avg
Panel avg: 89d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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.