Cleared Traditional

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

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

FDA 510(k) Submission Details - K070520

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
127d slower than avg
Panel avg: 115d · This submission: 242d
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 K070520.
MEDTRADE PRODUCTS CELOX TRAUMA GAUZE
K091795 · Medtrade Products , Ltd. · Nov 2009
MEDTRADE PRODUCTS CELOX HEMOSTATIC GRANULES ON SHEET
K080097 · Medtrade Products , Ltd. · Jul 2008
MEDTRADE PRODUCTS CELOX SOLBAG, ANTI - COAGULANT
K072328 · Medtrade Products , Ltd. · Dec 2007
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
K070175 · Medtrade Products , Ltd. · Jul 2007
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
K061079 · Medtrade Products , Ltd. · Jun 2006
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004