Cleared Traditional

K250420 - Helios Dura Regeneration Matrix

K250420 is an FDA 510(k) clearance for Helios Dura Regeneration Matrix, manufactured by Helios Biomedical, Inc.. The device is a Class 2 Neurology device with product code GXQ cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K250420 · Helios Biomedical, Inc. · Neurology device
Download Printable Device Report (PDF)
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May 2025
Decision
90d
Days
Class 2
Risk

K250420 is an FDA 510(k) clearance for the Helios Dura Regeneration Matrix. Classified as Dura Substitute (product code GXQ), Class II - Special Controls.

Submitted by Helios Biomedical, Inc. (Weston, US). The FDA issued a Cleared decision on May 14, 2025 after a review of 90 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5910 - 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 Helios Biomedical, Inc. devices

FDA 510(k) Submission Details - K250420

510(k) Number K250420 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2025
Decision Date May 14, 2025
Days to Decision 90 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
58d faster than avg
Panel avg: 148d · This submission: 90d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

GXQ Device Classification - Class 2, Special Controls

Product Code GXQ Dura Substitute
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5910
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 Consultant

QUARAS, LLC
Roshana Ahmed

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXQ Dura Substitute

All 32
Devices cleared under the same product code (GXQ) and FDA review panel - the closest regulatory comparables to K250420.
Collagen Dura Regeneration Membrane - Repair
K251191 · Collagen Matrix, Inc. · Nov 2025
ArtiFascia
K223445 · Nurami Medical , Ltd. · Aug 2023
SyntheCel Dura Repair
K212943 · Synthes USA Products, LLC · Jan 2022
XenoSure Dura Biologic Patch
K183513 · LeMaitre Vascular, Inc. · Jun 2019
DuraGen Secure Dural Regeneration Matrix
K163456 · Integra LifeSciences Corporation · Jan 2017
Durepair Dura Regeneration Matrix
K161370 · Medtronic Neurosurgery · Nov 2016