Cleared Traditional

K092552 - CLO-SURPLUS P.A.D.

K092552 · Scion Cardio-Vascular, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2009
Decision
15d
Days
-
Risk

K092552 is an FDA 510(k) clearance for the CLO-SURPLUS P.A.D.. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Scion Cardio-Vascular, Inc. (Miami, US). The FDA issued a Cleared decision on September 4, 2009 after a review of 15 days - a notably fast clearance cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

FDA 510(k) Submission Details - K092552

510(k) Number K092552 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2009
Decision Date September 04, 2009
Days to Decision 15 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
100d faster than avg
Panel avg: 115d · This submission: 15d
Pathway characteristics
Predicate-based equivalence.

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 K092552.
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K090780 · Medtrade Products , Ltd. · Nov 2009
MEDTRADE PRODUCTS CELOX TRAUMA GAUZE
K091795 · Medtrade Products , Ltd. · Nov 2009
CHITOGAUZE,2 IN X 2 IN,8 PLY, 4 IN X 4 IN 8 PLY, 4 IN X 8 IN, 8PLY, 1 IN X 4 IN, 8PLY, CHITOGAUZE, PACKAGING STRIP, 1/2
K092357 · Hem Con Medical Technologies, Inc. · Aug 2009
ALGISEAL PAD
K091194 · Evolution Medical Technologies, LLC · May 2009
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
K090620 · Z-Medica Corporation · Apr 2009
K092552 · CLO-SURPLUS P.A.D.
Download PDF FDA Summary Scion Cardio-Vascular…