510(K) CLEARANCES 67 ▼8RECALLS POSTED 26CLASS I 2PMA DECISIONS 40 ▼14WEEK ENDING / FDA DATA AS OF
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K080648Substantially Equivalent

Traumastat Rapid Hemostatic Wound Dressing Bandage

Ore-Medix, LLC, Midvale UT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K080648 is the FDA 510(k) clearance record for TRAUMASTAT RAPID HEMOSTATIC WOUND DRESSING BANDAGE, cleared for Ore-Medix, LLC 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 Ore-Medix, LLC. As of , FDA records show no recalls naming K080648.

Clearance record

Decision date
Received
(61 days to decision)
Product code
QSY Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device class
Unclassified
Review panel
Unknown
Applicant
Ore-Medix, LLC 7651 S 700 W., Midvale UT
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