Cleared Traditional

K100160 - ZZOMA POSITIONAL SLEEPER MODEL 001

K100160 is an FDA 510(k) clearance for ZZOMA POSITIONAL SLEEPER MODEL 001, manufactured by Sleep Specialists, LLC. The device is a Class 2 Ear, Nose, Throat device with product code MYB cleared through the Traditional 510(k) pathway after a 111-day FDA review.

K100160 · Sleep Specialists, LLC · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
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.

FDA 510(k) Submission Details - K100160

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
21d slower than avg
Panel avg: 90d · This submission: 111d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MYB Device Classification - Class 2, Special Controls

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.

Regulatory Peers - MYB Pillow, Cervical (for Mild Sleep Apnea)

Devices cleared under the same product code (MYB) and FDA review panel - the closest regulatory comparables to K100160.
Lunoa System
K180608 · Nightbalance BV · Jun 2018
NIGHT SHIFT
K140190 · Advanced Brain Monitoring, Inc. · May 2014
SONA PILLOW
K040161 · Sleep Devices, Inc. · Apr 2004
SNIFF POSITION PILLOWS/POPITZ PILLOWS
K023010 · Aeolus International Corporation · Oct 2002
PILLOWPOSITIVE CERVICAL PILLOW
K990871 · Lifesleep Systems, Inc. · Jun 1999