510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K950258Substantially Equivalent

Hemo-Barrier Tourniquet

Hemo-Barrier Technologies, Inc., Miami FL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K950258 is the FDA 510(k) clearance record for HEMO-BARRIER TOURNIQUET, cleared for Hemo-Barrier Technologies, Inc. on under FDA product code EFQ (Gauze/Sponge, Internal). FDA records list one 510(k) clearance for Hemo-Barrier Technologies, Inc. As of , FDA records show no recalls naming K950258.

Clearance record

Decision date
Received
(147 days to decision)
Product code
EFQ Gauze/Sponge, Internal
Device class
Unclassified
Review panel
Unknown
Applicant
Hemo-Barrier Technologies, Inc. 13727 SW 152 St. #231, Miami FL
510(k) summary
Summary
Third party review
No

Clearances, product code EFQ

Trailing 12 months

FDA records hold no clearances under product code EFQ in the trailing twelve months.

FDA records show no clearances under product code EFQ in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EFQ, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260