Cleared Abbreviated

K043050 - HEMCON BANDAGE AND HEMCON BANDAGE OTC

K043050 · 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 2005
Decision
211d
Days
-
Risk

K043050 is an FDA 510(k) clearance for the HEMCON BANDAGE AND 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 3, 2005 after a review of 211 days - an extended review cycle.

This device falls under the General & Plastic Surgery FDA review panel. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

FDA 510(k) Submission Details - K043050

510(k) Number K043050 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 04, 2004
Decision Date June 03, 2005
Days to Decision 211 days
Submission Type Abbreviated
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
96d slower than avg
Panel avg: 115d · This submission: 211d
Pathway characteristics
Standards-based clearance path.

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 K043050.
HEMOHALT HEMOSTASIS PAD
K060409 · Vanson-Halosource, Inc. · May 2006
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
K051955 · Z-Medica Corporation · Aug 2005
BIOPAD
K040283 · Euroresearch Srl · Jul 2005
QUIKCLOT BRAND HEMOSTATIC AGENT - ADVANCED BEADED FORMULATION - 100G - 1.9MM - 2.4MM., MODEL 100172
K050769 · Z-Medica Corporation · Apr 2005
NEPTUNE PAD, NEPTUNE DISC, NEPTUNE COMFORT-BAND, COMFORT-BAND
K040208 · Tz Medical, Inc. · May 2004
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004
K043050 · HEMCON BANDAGE AND HEMCON BANDAGE OTC
Download PDF FDA Summary Hemcon, Inc.