Cleared Traditional

K160130 - BloodSTOP iX Battle Matrix

K160130 · Lifescience Plus, Inc. · General & Plastic Surgery device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2016
Decision
161d
Days
-
Risk

K160130 is an FDA 510(k) clearance for the BloodSTOP iX Battle Matrix. Classified as Hemostatic Wound Dressing Without Thrombin Or Other Biologics (product code QSY).

Submitted by Lifescience Plus, Inc. (Mountain View, US). The FDA issued a Cleared decision on June 29, 2016 after a review of 161 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.

View all Lifescience Plus, Inc. devices

FDA 510(k) Submission Details - K160130

510(k) Number K160130 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 20, 2016
Decision Date June 29, 2016
Days to Decision 161 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
46d slower than avg
Panel avg: 115d · This submission: 161d
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 91
Devices cleared under the same product code (QSY) and FDA review panel - the closest regulatory comparables to K160130.
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Nustat XR
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Prometheus ChitoGauze XR PRO
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HemCon Bandage PRO, HemCon Patch PRO, HemCon Strip PRO, HemCon Strip First Aid PRO, ChitoFlex PRO
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