Cleared Traditional

K033666 - HEMADERM

K033666 · Medafor, Inc. · General & Plastic Surgery device
Download Printable Device Report (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.

View all Medafor, Inc. devices

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
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 47
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K033666.
AQUANOVA SUPER-ABSORBENT GELLING DRESSING, OTC
K070175 · Medtrade Products , Ltd. · Jul 2007
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
K061079 · Medtrade Products , Ltd. · Jun 2006
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
KALTOSTAT WOUND DRESSING
K910059 · Calgon Vestal Div. · Mar 1991
KALTOSTAT WOUND PACKING
K910080 · Calgon Vestal Div. · Mar 1991