Cleared Traditional

K190012 - OMNI-STAT Vascular (Rapid)

Also marketed or referenced as:
CELOX Vascular Rapid
K190012 · Medtrade Product, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2019
Decision
349d
Days
-
Risk

K190012 is an FDA 510(k) clearance for the OMNI-STAT Vascular (Rapid). Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Medtrade Product, Ltd. (Crewe, GB). The FDA issued a Cleared decision on December 18, 2019 after a review of 349 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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtrade Product, Ltd. devices

Submission Details

510(k) Number K190012 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2019
Decision Date December 18, 2019
Days to Decision 349 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
234d slower than avg
Panel avg: 115d · This submission: 349d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class -
Definition To Temporarily Control Bleeding And Cover External Wounds.

Regulatory Peers - QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics

All 28
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