Cleared Traditional

K151204 - HEMO-Bandage

K151204 · 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
Jul 2015
Decision
87d
Days
-
Risk

K151204 is an FDA 510(k) clearance for the HEMO-Bandage. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Coreleader Biotech Co., Ltd. (New Taipei City, TW). The FDA issued a Cleared decision on July 31, 2015 after a review of 87 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 - K151204

510(k) Number K151204 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 05, 2015
Decision Date July 31, 2015
Days to Decision 87 days
Submission Type Traditional
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
28d faster than avg
Panel avg: 115d · This submission: 87d
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 K151204.
Prometheus ChitoGauze XR PRO
K153582 · Hem Con Medical Technologies, Inc. · May 2016
HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
K150916 · Hem Con Medical Technologies, Inc. · Nov 2015
AnsCare ChitoClot Pad
K150963 · Benq Materials Corporation · Nov 2015
Hemogrip Patch
K143466 · Remedium Technologies, Inc. · Jun 2015
AnsCare ChitoClot Gauze (prescription use), AnsCare ChitoClot Gauze (over-the-counter use)
K143462 · Benq Materials Corporation · May 2015
NUSTAT, NUSTAT XR
K142363 · Beeken Biomedical · Jan 2015