Cleared Traditional

K103641 - GUARDACARE

K103641 · Hem Con Medical Technologies, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
185d
Days
-
Risk

K103641 is an FDA 510(k) clearance for the GUARDACARE. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hem Con Medical Technologies, Inc. (Portland, US). The FDA issued a Cleared decision on June 16, 2011 after a review of 185 days - an extended review 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: 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 - K103641

510(k) Number K103641 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 13, 2010
Decision Date June 16, 2011
Days to Decision 185 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
70d slower than avg
Panel avg: 115d · This submission: 185d
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 124
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K103641.
ADVANCED TRAUMA DRESSING (ATD)
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CLO-SURPLUS P.A.D.
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CORELEADER HEMO-PAD MODEL CPII 02030
K102944 · Coreleader Biotech Co., Ltd. · Sep 2011
CHITOGAUZE FUSION
K111163 · Hem Con Medical Technologies, Inc. · May 2011
CELOX RAPID GAUZE
K110386 · Medtrade Products , Ltd. · May 2011
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011