Cleared Traditional

K080210 - PRO QR ADVANCED FORMULA POWDER

K080210 · Biolife, LLC · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Feb 2009
Decision
379d
Days
-
Risk

K080210 is an FDA 510(k) clearance for the PRO QR ADVANCED FORMULA POWDER. 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 February 10, 2009 after a review of 379 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.

FDA 510(k) Submission Details - K080210

510(k) Number K080210 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 28, 2008
Decision Date February 10, 2009
Days to Decision 379 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
264d slower than avg
Panel avg: 115d · This submission: 379d
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 126
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K080210.
QUIKCLOT INTEVENTIONAL, MODEL P/N 182
K090620 · Z-Medica Corporation · Apr 2009
CHITOGAUZE, MODELS 130, 131, 263, 264, 265, 266
K090026 · Hem Con Medical Technologies, Inc. · Mar 2009
SOFTSEAL-STF
K090100 · Chitogen, Inc. · Mar 2009
BENACEL, MODELS C-001, C-002 AND C-005
K080532 · Unicare Biomedical, Inc. · Nov 2008
UltraClot, UltraClot OTC
K082601 · Emergency Medical Devices, LLC · Oct 2008
MODIFICATION TO HEMCON BANDAGE AND HEMCON BANDAGE OTC
K072486 · Hem Con Medical Technologies, Inc. · Aug 2008
K080210 · PRO QR ADVANCED FORMULA POWDER
Download PDF FDA Summary Biolife, LLC