Cleared Traditional

K182311 - Cervella

K182311 is an FDA 510(k) clearance for Cervella, manufactured by Innovative Neurological Devices, LLC. The device is a Class 2 Neurology device with product code QJQ cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K182311 · Innovative Neurological Devices, LLC · Neurology device
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Mar 2019
Decision
195d
Days
Class 2
Risk

K182311 is an FDA 510(k) clearance for the Cervella. Classified as Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety (product code QJQ), Class II - Special Controls.

Submitted by Innovative Neurological Devices, LLC (Carmel, US). The FDA issued a Cleared decision on March 7, 2019 after a review of 195 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5800 - the FDA neurology 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Innovative Neurological Devices, LLC devices

FDA 510(k) Submission Details - K182311

510(k) Number K182311 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 24, 2018
Decision Date March 07, 2019
Days to Decision 195 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
46d slower than avg
Panel avg: 149d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

QJQ Device Classification - Class 2, Special Controls

Product Code QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5800
Definition To Provide Electrical Current To The Head To Treat Insomnia And/or Anxiety
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.

Regulatory Peers - QJQ Cranial Electrotherapy Stimulator To Treat Insomnia And/or Anxiety

All 7
Devices cleared under the same product code (QJQ) and FDA review panel - the closest regulatory comparables to K182311.
Genesis Sleep
K252951 · Neurofield, Inc. · Dec 2025
Modius Stress
K232253 · Neurovalens Limited · Mar 2024
Modius Sleep
K230826 · Neurovalens , Ltd. · Oct 2023
CRANIAL ELECTRICAL NERVE STIMULATOR, MODEL FM 10/C
K090052 · Johari Digital Healthcare , Ltd. · May 2009
ELEXOMA MEDIC
K070412 · Redplane AG · May 2008
CES ULTRA
K062284 · Neuro-Fitness, LLC · Apr 2007