Not Cleared Direct

DEN200033 - NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple Watch Charging Cable (FDA 510(k) Clearance)

Class II Neurology device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN200033 · Nightware, Inc. · Neurology device
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Nov 2020
Decision
163d
Days
Class 2
Risk

DEN200033 is an FDA 510(k) submission (not cleared) for the NightWare Kit, Apple iPhone, Apple Watch, Apple iPhone Charging Cable, Apple .... Classified as Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions (product code QMZ), Class II - Special Controls.

Submitted by Nightware, Inc. (Hopkins, US). The FDA issued a Not Cleared (DENG) decision on November 6, 2020 after a review of 163 days.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5705 - the FDA neurology device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. This submission did not achieve clearance, indicating the FDA determined the device lacked sufficient predicate equivalence under the Neurology review framework.

View all Nightware, Inc. devices

Submission Details

510(k) Number DEN200033 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received May 27, 2020
Decision Date November 06, 2020
Days to Decision 163 days
Submission Type Direct
Review Panel Neurology (NE)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d slower than avg
Panel avg: 148d · This submission: 163d
Pathway characteristics

Device Classification

Product Code QMZ Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5705
Definition A Digital Therapy Device To Reduce Sleep Disturbance For Psychiatric Conditions Is A Prescription Device That Is Intended To Provide Stimulation Using A General Purpose Computing Platform To Reduce Sleep Disturbance In Patients Who Experience This Symptom Due To Psychiatric Conditions Such As Nightmare Disorder Or Post Traumatic Stress Disorder (ptsd).
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 Neurology devices follow this clearance model.