Cleared Traditional

K254216 - Enso for Migraine

K254216 is an FDA 510(k) clearance for Enso for Migraine, manufactured by Hinge Health, Inc.. The device is a Class 2 Neurology device with product code PCC cleared through the Traditional 510(k) pathway after a 108-day FDA review.

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

FDA 510(k) Submission Details - K254216

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.

PCC Device Classification - Class 2, Special Controls

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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