Cleared Traditional

K102944 - CORELEADER HEMO-PAD MODEL CPII 02030

K102944 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Sep 2011
Decision
338d
Days
-
Risk

K102944 is an FDA 510(k) clearance for the CORELEADER HEMO-PAD MODEL CPII 02030. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Coreleader Biotech Co., Ltd. (Taipei, Taiwan, TW). The FDA issued a Cleared decision on September 7, 2011 after a review of 338 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K102944

510(k) Number K102944 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 04, 2010
Decision Date September 07, 2011
Days to Decision 338 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
223d slower than avg
Panel avg: 115d · This submission: 338d
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 124
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K102944.
HEMCON HEMOSTATIC GEL
K112215 · Hemcon Medical Technologies Europe, Ltd. · Apr 2012
ADVANCED TRAUMA DRESSING (ATD)
K101257 · Nanosys, Inc. · Dec 2011
CLO-SURPLUS P.A.D.
K112961 · Scion Cardio-Vascular, Inc. · Oct 2011
GUARDACARE
K103641 · Hem Con Medical Technologies, Inc. · Jun 2011
CHITOGAUZE FUSION
K111163 · Hem Con Medical Technologies, Inc. · May 2011
CELOX RAPID GAUZE
K110386 · Medtrade Products , Ltd. · May 2011