Cleared Traditional

K102944 - CORELEADER HEMO-PAD MODEL CPII 02030

K102944 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Coreleader Biotech Co., Ltd. devices

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 47
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K102944.
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CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
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K102965 · Medtrade Products , Ltd. · Dec 2010