Cleared Traditional

K021678 - HEMADERM COTAINING HEMADEX CLOTTING BEADS

K021678 · Medafor, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jul 2002
Decision
52d
Days
-
Risk

K021678 is an FDA 510(k) clearance for the HEMADERM COTAINING HEMADEX CLOTTING BEADS. 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 July 12, 2002 after a review of 52 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 - K021678

510(k) Number K021678 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 21, 2002
Decision Date July 12, 2002
Days to Decision 52 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
63d faster than avg
Panel avg: 115d · This submission: 52d
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 K021678.
HEMCON BANDAGE
K023298 · Hemcon, Inc. · Nov 2002
CHITO-SEAL
K021062 · Abbott Vascular, Inc. · Aug 2002
HEMOSORB
K021581 · On Site Gas Systems, Inc. · Jul 2002
QUICKCLOT
K013390 · On Site Gas Systems, Inc. · May 2002
SEAL-ON TOPICAL HEMPSTATIC POWDER SPRAY
K010933 · Alltracel Pharma , Ltd. · Jan 2002
3M TEGAGEN HI ALGINATE DRESSING & 3 M TEGAGEN HG ALGINATE DRESSING, MODEL #'S 90110,90112,90114,90120, 90210,90212,90214
K982638 · Innovative Technologies , Ltd. · Aug 1998
K021678 · HEMADERM COTAINING HEMADEX CLOTTING BEADS
Download PDF FDA Summary Medafor, Inc.