Cleared Traditional

K070520 - PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCEDURES) (FDA 510(k) Clearance)

K070520 · Biolife, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2007
Decision
242d
Days
-
Risk

K070520 is an FDA 510(k) clearance for the PRO QR (QUICK RELIEF) POWDER (FOR MINOR EXTERNAL BLEEDING FROM WOUNDS & PROCE.... Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Biolife, LLC (Sarasota, US). The FDA issued a Cleared decision on October 23, 2007 after a review of 242 days - an extended review 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: Standard predicate-based submission. Standard predicate reliance. 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 Biolife, LLC devices

Submission Details

510(k) Number K070520 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2007
Decision Date October 23, 2007
Days to Decision 242 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
128d slower than avg
Panel avg: 114d · This submission: 242d
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 K070520.
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