Not Cleared Direct

DEN210049 - Medline ART Skin Harvesting System (FDA 510(k) Clearance)

Class II General & Plastic Surgery device cleared through the Direct 510(k) pathway - typically does not require clinical trials.

DEN210049 · Medline Industries, Inc. · General & Plastic Surgery device
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Mar 2024
Decision
890d
Days
Class 2
Risk

DEN210049 is an FDA 510(k) submission (not cleared) for the Medline ART Skin Harvesting System. Classified as Semi-automated Autologous Skin Graft Harvesting And Application Device (product code QYK), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Northfiled, US). The FDA issued a Not Cleared (DENG) decision on March 27, 2024 after a review of 890 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4795 - the FDA general and plastic surgery device framework. The Traditional 510(k) pathway requires demonstration of substantial equivalence to a legally marketed predicate device - a standard the FDA determined was not met in this submission.

Device pattern: Regulatory edge-case submission. High predicate equivalence gap. With 890 days under review and no clearance granted, this submission reflects a case where the FDA could not confirm sufficient predicate equivalence - often indicating either a novel device category or unresolved safety and performance questions.

View all Medline Industries, Inc. devices

Submission Details

510(k) Number DEN210049 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received October 19, 2021
Decision Date March 27, 2024
Days to Decision 890 days
Submission Type Direct
Review Panel General & Plastic Surgery (SU)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
776d slower than avg
Panel avg: 114d · This submission: 890d
Pathway characteristics

Device Classification

Product Code QYK Semi-automated Autologous Skin Graft Harvesting And Application Device
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4795
Definition A Semi- Automated Autologous Skin Graft Harvesting And Application Device Is A Handheld Electromechanical Surgical Instrument That Extracts Autologous Skin Graft Tissue From A Healthy Donor Skin Site And Deposits It To A Recipient Site. The Device Extraction And Deposition Functions Are Automated And Are Activated By The User. The Device Is Not Intended For Treatment Of Third Degree Burns.
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 General & Plastic Surgery devices follow this clearance model.