Cleared Traditional

K254216 - Enso for Migraine (FDA 510(k) Clearance)

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

K254216 · Hinge Health, Inc. · Neurology device
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Apr 2026
Decision
108d
Days
Class 2
Risk

K254216 is an FDA 510(k) clearance for the Enso for Migraine. Classified as Stimulator, Nerve, Electrical, Transcutaneous, For Migraine (product code PCC), Class II - Special Controls.

Submitted by Hinge Health, Inc. (San Francisco, US). The FDA issued a Cleared decision on April 16, 2026 after a review of 108 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5891 - 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 Hinge Health, Inc. devices

Submission Details

510(k) Number K254216 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 29, 2025
Decision Date April 16, 2026
Days to Decision 108 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
40d faster than avg
Panel avg: 148d · This submission: 108d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5891
Definition Used To Apply An Electrical Current To A Patient's Cranium Through Electrodes Placed On The Skin.
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 - PCC Stimulator, Nerve, Electrical, Transcutaneous, For Migraine

All 17
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