Cleared Traditional

Omeza Collagen Matrix (K211972) - FDA 510(k) Clearance

K211972 · Omeza, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2021
Decision
69d
Days
-
Risk

K211972 is an FDA 510(k) clearance for the Omeza Collagen Matrix. Classified as Dressing, Wound, Drug (product code FRO).

Submitted by Omeza, LLC (Sarasota, US). The FDA issued a Cleared decision on September 1, 2021 after a review of 69 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 Omeza, LLC devices

Submission Details

510(k) Number K211972 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 24, 2021
Decision Date September 01, 2021
Days to Decision 69 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
46d faster than avg
Panel avg: 115d · This submission: 69d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code FRO Dressing, Wound, Drug
Device Class -

Regulatory Consultant

Hogan Lovells US LLP
Randy Prebula

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - FRO Dressing, Wound, Drug

All 168
Devices cleared under the same product code (FRO) and FDA review panel - the closest regulatory comparables to K211972.
Silver Gelling Fiber Dressing
K210466 · Winner Medical Co., Ltd. · Jan 2022
Silver Alginate Dressing (Prescription use), Antibacterial Alginate Would Dressing (OTC use)
K202982 · Winner Medical Co., Ltd. · Oct 2021
TorrentX Wound Wash
K203446 · Next Science, LLC · Sep 2021
High Performance Antimicrobial Gelling Fiber with Silver
K210974 · Advanced Medical Solutions, Ltd. · May 2021
MIS Solution
K203835 · Next Science, LLC · Apr 2021
AMSure® Single Use Saline Topical Solution
K201138 · Amsino Medical, Inc. · Apr 2021