QUIKCLOT EX— 510(k) K072474

Name: FDA 510(k) clearance K072474
Creator: U.S. Food and Drug Administration
Published: 2007-10-16

Substantially Equivalent

Z-Medica Corporation

FDA 510(k) clearance K072474 for QUIKCLOT EX, Substantially Equivalent on 2007-10-16. Applicant: Z-Medica Corporation. Device class: Unclassified.

Clearance details

Applicant: Z-Medica Corporation
Product code: Code QSY
Device class: Unclassified
Advisory panel: Unknown
Date received: 2007-09-04
Decision date: 2007-10-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code QSY

view all

K253017 — BloodSTOP iX Trauma Matrix (TM-iX-20)2026-04-30
K251700 — Ganymede 2cm diameter (FG100300) +14 more2026-02-26
K250319 — MFUSE (MS001)2025-12-15
K253609 — TRAUMAGEL® 2.0 Hemostatic Gel2025-12-12
K240713 — TRAUMAGEL®2024-08-14

More clearances from Z-Medica Corporation

view all

K120782 — INTERVENTIONAL HEMOSTATIC BANDAGE2013-03-20
K090620 — QUIKCLOT INTEVENTIONAL, MODEL P/N 1822009-04-08
K080247 — QUIKCLOT NOSEBLEED2008-02-27
K070010 — QUIKCLOT SPORT AND QUIKCLOT SPORT SILVER2007-01-25
K061767 — QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+2006-07-19

Adverse events under product code QSY

product code QSY

Death: 5
Other: 1
Total: 6

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

Recalls naming K072474

K-number listed on FDA's recall record

Z-0211-2022 — QuikClot Combat Gauze-For Temporary External Use To Control Traumatic Bleeding Model / Part# 200Class II·Terminated·Z-Medica, LLC·20210922

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K072474.

Data sourced from openFDA. This site is unofficial and independent of the FDA.