Cleared Special

K051955 - QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE

K051955 · Z-Medica Corporation · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
22d
Days
-
Risk

K051955 is an FDA 510(k) clearance for the QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Z-Medica Corporation (Wallingford, US). The FDA issued a Cleared decision on August 10, 2005 after a review of 22 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K051955

510(k) Number K051955 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 19, 2005
Decision Date August 10, 2005
Days to Decision 22 days
Submission Type Special
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
93d faster than avg
Panel avg: 115d · This submission: 22d
Pathway characteristics
Modification to existing cleared device.

QSY Device Classification - Class 0,

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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K051955.
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
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MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
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BIOPAD
K040283 · Euroresearch Srl · Jul 2005
HEMCON BANDAGE AND HEMCON BANDAGE OTC
K043050 · Hemcon, Inc. · Jun 2005
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
K050769 · Z-Medica Corporation · Apr 2005
K051955 · QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
Download PDF FDA Summary Z-Medica Corporation