Cleared Traditional

K121485 - GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DR...

K121485 · Hemcon Medical Technologies Europe, Ltd. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2012
Decision
95d
Days
-
Risk

K121485 is an FDA 510(k) clearance for the GUARDIVA ANTIMICROBIAL HAEMSTATIC IV DRESSING. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Hemcon Medical Technologies Europe, Ltd. (Portland, US). The FDA issued a Cleared decision on August 21, 2012 after a review of 95 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.

View all Hemcon Medical Technologies Europe, Ltd. devices

FDA 510(k) Submission Details - K121485

510(k) Number K121485 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 18, 2012
Decision Date August 21, 2012
Days to Decision 95 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
20d faster than avg
Panel avg: 115d · This submission: 95d
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 31
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K121485.
gel-e Flex
K180152 · Gel-E, Inc. · Jun 2018
StatGuard Hemostatic Patch, StatGuard Hemostatic Dressing
K172155 · Statguard, LLC · Apr 2018
Axiostat Chitosan Hemostatic Dressing
K172324 · Advamedica, Inc. · Feb 2018
SUNTOUCH TOPICAL HEMOSTATIC DRESSING
K112800 · Huizhou Foryou Medical Devices Co., Ltd. · May 2012
CELSTAT
K103245 · Baxter Healthcare Corp · Mar 2011
TOPSEAL HEMOSTATIC DRESSING, MODEL 11150
K033291 · Radi Medical Systems AB · Mar 2004