Cleared Traditional

K210135 - PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing (FDA 510(k) Clearance)

K210135 · 3M Healthcare Business Group · General & Plastic Surgery device

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Feb 2022

Decision

401d

Days

Risk

K210135 is an FDA 510(k) clearance for the PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by 3M Healthcare Business Group (Berkshire, Bracknell Forest, GB). The FDA issued a Cleared decision on February 24, 2022 after a review of 401 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.

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Submission Details

510(k) Number	K210135 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 19, 2021
Decision Date	February 24, 2022
Days to Decision	401 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF
Third-party Review	No - reviewed directly by FDA
PCCP Authorized	No