Not Cleared Direct

DEN160012 - D2 Dressing (FDA 510(k) Clearance)

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

DEN160012 · Z-Medica, LLC · General & Plastic Surgery device
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Jun 2017
Decision
471d
Days
Class 2
Risk

DEN160012 is an FDA 510(k) submission (not cleared) for the D2 Dressing. Classified as Temporary, Internal Use Hemostatic (product code POD), Class II - Special Controls.

Submitted by Z-Medica, LLC (Wallingford, US). The FDA issued a Not Cleared (DENG) decision on June 30, 2017 after a review of 471 days.

This device falls under the General & Plastic Surgery FDA review panel, regulated under 21 CFR 878.4454 - 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 471 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.

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Submission Details

510(k) Number DEN160012 FDA.gov
FDA Decision Not Cleared Not Substantially Equivalent (DENG)
Date Received March 16, 2016
Decision Date June 30, 2017
Days to Decision 471 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
357d slower than avg
Panel avg: 114d · This submission: 471d
Pathway characteristics

Device Classification

Product Code POD Temporary, Internal Use Hemostatic
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4454
Definition Intended To Control Severely Bleeding Wounds
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.