Cleared Traditional

K033666 - HEMADERM

K033666 · Medafor, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2003
Decision
26d
Days
-
Risk

K033666 is an FDA 510(k) clearance for the HEMADERM. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Medafor, Inc. (Minneapolis, US). The FDA issued a Cleared decision on December 17, 2003 after a review of 26 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 - K033666

510(k) Number K033666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 21, 2003
Decision Date December 17, 2003
Days to Decision 26 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
89d faster than avg
Panel avg: 115d · This submission: 26d
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 125
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K033666.
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
CLO-SURPLUSP.A.D.
K032986 · Scion Cardio-Vascular, Inc. · Mar 2004
HEMCON BANDAGE OTC
K030946 · Hemcon, Inc. · Jun 2003
T-SCIENTIFIC T-PAD
K030334 · T-Scientific, Inc. · Apr 2003
HEMCON BANDAGE
K023298 · Hemcon, Inc. · Nov 2002
K033666 · HEMADERM
Download PDF FDA Summary Medafor, Inc.