Cleared Traditional

K191830 - gammaCore Sapphire (FDA 510(k) Clearance)

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

K191830 · Electrocore, Inc. · Neurology device
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Mar 2020
Decision
261d
Days
Class 2
Risk

K191830 is an FDA 510(k) clearance for the gammaCore Sapphire. Classified as Non-invasive Vagus Nerve Stimulator - Headache (product code PKR), Class II - Special Controls.

Submitted by Electrocore, Inc. (Basking Ridge, US). The FDA issued a Cleared decision on March 26, 2020 after a review of 261 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5892 - 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 Electrocore, Inc. devices

Submission Details

510(k) Number K191830 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 09, 2019
Decision Date March 26, 2020
Days to Decision 261 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
113d slower than avg
Panel avg: 148d · This submission: 261d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PKR Non-invasive Vagus Nerve Stimulator - Headache
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5892
Definition The Device Intended For Non-invasive Vagus Nerve Stimulation (nvns) On The Side Of The Neck To Treat Cluster Headache And To Reduce The Frequency Of Cluster Headache Attacks.
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.