Cleared Traditional

Miro3D Wound Matrix (K221520) - FDA 510(k) Clearance

K221520 · Reprise Biomedical, Inc. · General & Plastic Surgery device
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Aug 2022
Decision
85d
Days
-
Risk

K221520 is an FDA 510(k) clearance for the Miro3D Wound Matrix. Classified as Wound Dressing With Animal-derived Material(s) (product code KGN).

Submitted by Reprise Biomedical, Inc. (Plymouth, US). The FDA issued a Cleared decision on August 18, 2022 after a review of 85 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Reprise Biomedical, Inc. devices

Submission Details

510(k) Number K221520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 25, 2022
Decision Date August 18, 2022
Days to Decision 85 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
30d faster than avg
Panel avg: 115d · This submission: 85d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code KGN Wound Dressing With Animal-derived Material(s)
Device Class -

Regulatory Peers - KGN Wound Dressing With Animal-derived Material(s)

All 73
Devices cleared under the same product code (KGN) and FDA review panel - the closest regulatory comparables to K221520.
InnovaBurn
K213716 · Triad Life Sciences, Inc. · Sep 2022
InnovaMatrix PD
K211902 · Triad Life Sciences, Inc. · Sep 2022
LUOFUCON Collagen Wound Dressing
K213598 · Huizhou Foryou Medical Devices Co., Ltd. · Sep 2022
Foundation Dermal Regeneration Scaffold (DRS) Solo
K210949 · Bionova Medical, Inc. · Aug 2022
PELNAC Meshed Bilayer Wound Matrix
K213498 · Gunze Limited · Jul 2022
PuraPly Micronized Wound Matrix (PuraPly MZ)
K220317 · Organogenesis, Inc. · Jul 2022