Cleared Traditional

K140190 - NIGHT SHIFT

K140190 is an FDA 510(k) clearance for NIGHT SHIFT, manufactured by Advanced Brain Monitoring, Inc.. The device is a Class 2 Ear, Nose, Throat device with product code MYB cleared through the Traditional 510(k) pathway after a 125-day FDA review.

K140190 · Advanced Brain Monitoring, Inc. · Ear, Nose, Throat device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2014
Decision
125d
Days
Class 2
Risk

K140190 is an FDA 510(k) clearance for the NIGHT SHIFT. Classified as Pillow, Cervical (for Mild Sleep Apnea) (product code MYB), Class II - Special Controls.

Submitted by Advanced Brain Monitoring, Inc. (Dousman, US). The FDA issued a Cleared decision on May 29, 2014 after a review of 125 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 - K140190

510(k) Number K140190 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 24, 2014
Decision Date May 29, 2014
Days to Decision 125 days
Submission Type Traditional
Review Panel Ear, Nose, Throat (EN)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d slower than avg
Panel avg: 90d · This submission: 125d
Pathway characteristics
Predicate-based equivalence.

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. Clinical trial data may be submitted as supporting evidence to strengthen the substantial equivalence argument. Most Ear, Nose, Throat devices follow this clearance model.

Clinical Evidence

ClinicalTrials.gov
NCT02032706 Completed Interventional Industry-sponsored

Validation of Safety and Efficacy for Night Shift Therapy

36
Patients (actual)
1
Site
Treatment
Purpose
Open label
Masking
Condition studied Obstructive Sleep Apnea
Study design Single group
Eligibility All sexes · 18 Years+
Principal investigator Daniel J Levendowski, MBA
Sponsor Advanced Brain Monitoring, Inc. (industry)
Started 2013-06-01 → Primary completion 2014-02-01
Primary outcome
Percentage of Participants Who Completed the Study at 4 Weeks Without Adverse Events
Secondary outcome
Confirmation That Night Shift Accurately Detects Supine Position
View full study on ClinicalTrials.gov

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 K140190.
Lunoa System
K180608 · Nightbalance BV · Jun 2018
ZZOMA POSITIONAL SLEEPER MODEL 001
K100160 · Sleep Specialists, LLC · May 2010
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