Cleared Traditional

BTM Wound Dressing (K142879) - FDA 510(k) Clearance

K142879 · Polynovo Biomaterials Pty, Ltd. · General & Plastic Surgery device
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Optimized for regulatory review, auditing and printing
Dec 2015
Decision
447d
Days
-
Risk

K142879 is an FDA 510(k) clearance for the BTM Wound Dressing. Classified as Absorbable Synthetic Wound Dressing (product code QSZ).

Submitted by Polynovo Biomaterials Pty, Ltd. (Port Melbourne, AU). The FDA issued a Cleared decision on December 23, 2015 after a review of 447 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind General & Plastic Surgery submissions.

View all Polynovo Biomaterials Pty, Ltd. devices

Submission Details

510(k) Number K142879 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 02, 2014
Decision Date December 23, 2015
Days to Decision 447 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
332d slower than avg
Panel avg: 115d · This submission: 447d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSZ Absorbable Synthetic Wound Dressing
Device Class -
Definition Intended As A Physical Barrier To Cover The Wound And Provide A Moist Wound Environment. Intended To Be Left On Wounds After Topical Application.