Cleared Traditional

Cervella (K182311) - FDA 510(k) Clearance

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
47d slower than avg
Panel avg: 148d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.