Cleared Traditional

K060409 - HEMOHALT HEMOSTASIS PAD

K060409 · Vanson-Halosource, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
May 2006
Decision
90d
Days
-
Risk

K060409 is an FDA 510(k) clearance for the HEMOHALT HEMOSTASIS PAD. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Vanson-Halosource, Inc. (Redmond, US). The FDA issued a Cleared decision on May 17, 2006 after a review of 90 days - within the typical 510(k) review window.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the General & Plastic Surgery review framework, consistent with the majority of Class II 510(k) submissions.

FDA 510(k) Submission Details - K060409

510(k) Number K060409 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 16, 2006
Decision Date May 17, 2006
Days to Decision 90 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
25d faster than avg
Panel avg: 115d · This submission: 90d
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 K060409.
BLOXX RAPID CLOTTING AGENT
K061722 · Crosslink-D, Inc. · Aug 2006
QUIKCLOT 1ST RESPONSE & QUIKCLOT ACS+
K061767 · Z-Medica Corporation · Jul 2006
MEDTRADE PRODUCTS CELOX TOPICAL HEMOSTATIC GRANULES, MEDTRADE PRODUCTS CELOX 762 HEMOSTATIC GRANULES
K061079 · Medtrade Products , Ltd. · Jun 2006
QUICKCLOT ACS - ACCELERATED CLOTTING SPONGE
K051955 · Z-Medica Corporation · Aug 2005
BIOPAD
K040283 · Euroresearch Srl · Jul 2005
HEMCON BANDAGE AND HEMCON BANDAGE OTC
K043050 · Hemcon, Inc. · Jun 2005
K060409 · HEMOHALT HEMOSTASIS PAD
Download PDF FDA Summary Vanson-Halosource, In…