Cleared Traditional

K250115 - Hemastyl(™) Wound Dressing (FDA 510(k) Clearance)

K250115 · Rapid Nexus Nanotech Wound Solutions, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2025
Decision
271d
Days
-
Risk

K250115 is an FDA 510(k) clearance for the Hemastyl(™) Wound Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Rapid Nexus Nanotech Wound Solutions, Inc. (Brea, US). The FDA issued a Cleared decision on October 14, 2025 after a review of 271 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. 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 General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Rapid Nexus Nanotech Wound Solutions, Inc. devices

Submission Details

510(k) Number K250115 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 2025
Decision Date October 14, 2025
Days to Decision 271 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
157d slower than avg
Panel avg: 114d · This submission: 271d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Schuler Medical Device
Denise Holliday

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 - FRO Dressing, Wound, Drug

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