K253017 - BloodSTOP iX Trauma Matrix (TM-iX-20) (FDA 510(k) Clearance)

K253017 is an FDA 510(k) clearance for the BloodSTOP iX Trauma Matrix (TM-iX-20). 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 April 30, 2026 after a review of 223 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.

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