Cleared Traditional

K151204 - HEMO-Bandage (FDA 510(k) Clearance)

K151204 · Coreleader Biotech Co., Ltd. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Coreleader Biotech Co., Ltd. devices

Submission Details

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
Regulatory Context
Review time vs. panel average
27d faster than avg
Panel avg: 114d · This submission: 87d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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 K151204.
BloodSTOP iX Trauma Matrix (TM-iX-20)
K253017 · Lifescience Plus, Inc. · Apr 2026
Ganymede 2cm diameter (FG100300)
K251700 · Speciality Fibres and Materials Limited · Feb 2026
MFUSE (MS001)
K250319 · Machina Medical, Inc. · Dec 2025
TRAUMAGEL® 2.0 Hemostatic Gel
K253609 · Cresilon, Inc. · Dec 2025
TRAUMAGEL®
K240713 · Cresilon, Inc. · Aug 2024
Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5)
K240097 · Ushare Medical, Inc. · May 2024