Cleared Traditional Expedited

K013390 - QUICKCLOT

K013390 · On Site Gas Systems, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2002
Decision
220d
Days
-
Risk

K013390 is an FDA 510(k) clearance for the QUICKCLOT. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by On Site Gas Systems, Inc. (Newington, US). The FDA issued a Cleared decision on May 23, 2002 after a review of 220 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.

FDA 510(k) Submission Details - K013390

510(k) Number K013390 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 15, 2001
Decision Date May 23, 2002
Days to Decision 220 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
105d slower than avg
Panel avg: 115d · This submission: 220d
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 K013390.
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
HEMOSORB
K021581 · On Site Gas Systems, Inc. · Jul 2002
HEMADERM COTAINING HEMADEX CLOTTING BEADS
K021678 · Medafor, Inc. · Jul 2002
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
K010933 · Alltracel Pharma , Ltd. · Jan 2002
3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
K982638 · Innovative Technologies , Ltd. · Aug 1998
SORBASTACE
K965034 · Hemostace, LLC · Apr 1998