Cleared Traditional

K030946 - HEMCON BANDAGE OTC

Also marketed or referenced as:
HEMCON CATH/AID
K030946 · Hemcon, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2003
Decision
85d
Days
-
Risk

K030946 is an FDA 510(k) clearance for the HEMCON BANDAGE OTC. 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 June 19, 2003 after a review of 85 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 - K030946

510(k) Number K030946 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 26, 2003
Decision Date June 19, 2003
Days to Decision 85 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
30d faster than avg
Panel avg: 115d · This submission: 85d
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 K030946.
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004
CLO-SURPLUSP.A.D.
K032986 · Scion Cardio-Vascular, Inc. · Mar 2004
HEMADERM
K033666 · Medafor, Inc. · Dec 2003
T-SCIENTIFIC T-PAD
K030334 · T-Scientific, Inc. · Apr 2003
HEMCON BANDAGE
K023298 · Hemcon, Inc. · Nov 2002
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
K030946 · HEMCON BANDAGE OTC
Download PDF FDA Summary Hemcon, Inc.