510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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ManufacturingTHE TRADE PAPER OF THE FACTORY FLOOR
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K190012Substantially Equivalent

OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid

Medtrade Product, Ltd., Crewe, GB / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K190012 is the FDA 510(k) clearance record for OMNI-STAT Vascular (Rapid); CELOX Vascular Rapid, cleared for Medtrade Product, Ltd. on under FDA product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics). FDA's definition for product code QSY reads: "To temporarily control bleeding and cover external wounds". FDA records list one 510(k) clearance for Medtrade Product, Ltd. As of , FDA records show no recalls naming K190012.

Clearance record

Decision date
Received
(349 days to decision)
Product code
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Medtrade Product, Ltd. Electra House, Electra Way, Crewe Business Park, Crewe, GB
510(k) summary
Summary PDF
Third party review
No

Clearances, product code QSY

Trailing 12 months
4 clearances under product code QSY in the twelve months to October 2026, December 2025 the highest month at 2.
Show the numbers
Monthly 510(k) clearances under FDA product code QSY, trailing twelve months
MonthClearances
November 20250
December 20252
January 20260
February 20261
March 20260
April 20261
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260