BloodSTOP iX Trauma Matrix (TM-iX-20)— 510(k) K253017
Substantially EquivalentLifescience Plus, Inc.
FDA 510(k) clearance K253017 for BloodSTOP iX Trauma Matrix (TM-iX-20), Substantially Equivalent on 2026-04-30. Applicant: Lifescience Plus, Inc.. Device class: Unclassified.
Summary
Lifescience Plus's BloodSTOP iX Trauma Matrix (TM-iX-20) is filed under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics).
Class U, with no regulation number. The classification panel is listed as Unknown, and the General and Plastic Surgery review panel handled it as a Traditional 510(k).
Lifescience Plus filed from Mountain View, California. Review took 223 calendar days (September 19, 2025 to April 30, 2026).
Clearance details
- Applicant
- Lifescience Plus, Inc.
- Product code
- Product code QSY
- Device class
- Unclassified
- Advisory panel
- Unknown
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- Mountain View, CA, US
Recent devices under product code QSY
view allMore clearances from Lifescience Plus, Inc.
view allAdverse events under product code QSY
product code QSY- Death
- 5
- Other
- 1
- Total
- 6
Source: openFDA MAUDE database, through . Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →
Data sourced from openFDA. This site is unofficial and independent of the FDA.