Cleared Traditional Expedited

K023298 - HEMCON BANDAGE

K023298 · Hemcon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Nov 2002
Decision
32d
Days
-
Risk

K023298 is an FDA 510(k) clearance for the HEMCON BANDAGE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemcon, Inc. (Portland, US). The FDA issued a Cleared decision on November 4, 2002 after a review of 32 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.

FDA 510(k) Submission Details - K023298

510(k) Number K023298 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 03, 2002
Decision Date November 04, 2002
Days to Decision 32 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
83d faster than avg
Panel avg: 115d · This submission: 32d
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 K023298.
HEMADERM
K033666 · Medafor, Inc. · Dec 2003
HEMCON BANDAGE OTC
K030946 · Hemcon, Inc. · Jun 2003
T-SCIENTIFIC T-PAD
K030334 · T-Scientific, Inc. · Apr 2003
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
K023298 · HEMCON BANDAGE
Download PDF FDA Summary Hemcon, Inc.