Cleared Traditional

PROMOGRAN PRISMA Matrix, Small Dressing, PROMOGRAN PRISMA Matrix, Large Dressing (K210135) - 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.

View all 3M Healthcare Business Group devices

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
Regulatory Context
Review time vs. panel average
286d slower than avg
Panel avg: 115d · This submission: 401d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Peers - FRO Dressing, Wound, Drug

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