Cleared Traditional

K142363 - NUSTAT, NUSTAT XR

K142363 · Beeken Biomedical · General & Plastic Surgery device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
137d
Days
-
Risk

K142363 is an FDA 510(k) clearance for the NUSTAT, NUSTAT XR. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Beeken Biomedical (Raleigh, US). The FDA issued a Cleared decision on January 9, 2015 after a review of 137 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 - K142363

510(k) Number K142363 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 25, 2014
Decision Date January 09, 2015
Days to Decision 137 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
22d slower than avg
Panel avg: 115d · This submission: 137d
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 K142363.
HEMO-Bandage
K151204 · Coreleader Biotech Co., Ltd. · Jul 2015
Hemogrip Patch
K143466 · Remedium Technologies, Inc. · Jun 2015
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K143462 · Benq Materials Corporation · May 2015
WOUNDCLOT HEMOSTATIC GAUZE
K140573 · Core Scientific , Ltd. · Nov 2014
STOPSBLEEDING TOPICAL HEMOSTAT POWDER AND FOAM
K140313 · Coag Medical, LLC · Jul 2014
D2 HEMOSTANTIC DRESSING
K140757 · Z-Medica, LLC · Jul 2014