Cleared Traditional

Helios Dura Regeneration Matrix

K250420 · Helios Biomedical, Inc. · Neurology

May 2025

Decision

90d

Days

Class 2

Risk

About This 510(k) Submission

K250420 is an FDA 510(k) clearance for the Helios Dura Regeneration Matrix, a Dura Substitute (Class II — Special Controls, product code GXQ), submitted by Helios Biomedical, Inc. (Weston, US). The FDA issued a Cleared decision on May 14, 2025, 90 days after receiving the submission on February 13, 2025. This device falls under the Neurology review panel. Regulated under 21 CFR 882.5910.

Submission Details

510(k) Number	K250420 FDA.gov
FDA Decision	Cleared 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