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510(k) K253017

BloodSTOP iX Trauma Matrix (TM-iX-20) by Lifescience Plus, Inc. — Product Code QSY

K253017 is an FDA 510(k) premarket notification submitted by Lifescience Plus, Inc. for the device "BloodSTOP iX Trauma Matrix (TM-iX-20)". The FDA issued a decision of Substantially Equivalent on April 30, 2026. The device falls under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics), a Class U device. Lifescience Plus, Inc. has at least 3 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 30, 2026
Date Received
September 19, 2025
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Hemostatic Wound Dressing Without Thrombin Or Other Biologics
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

To temporarily control bleeding and cover external wounds.

Other clearances by Lifescience Plus, Inc.

  • K160130 — BloodSTOP iX Battle Matrix (June 29, 2016)
  • K072681 — BLOODSTOP HEMOSTATIC GAUZE; IX HEMOSTATIC GAUZE (November 2, 2007)
  • K071578 — BLOODSTOP AND BLOODSTOP IX HEMOSTATIC GAUZE, MODELS BS-10,BS-11,BS-12,B-13, BS (September 27, 2007)

Other clearances for product code QSY

  • K251700 — Ganymede 2cm diameter (FG100300); Ganymede 5cm x 5cm (FG100400); Ganymede 10cm x (February 26, 2026)
  • K250319 — MFUSE (MS001) (December 15, 2025)
  • K253609 — TRAUMAGEL® 2.0 Hemostatic Gel (December 12, 2025)
  • K240713 — TRAUMAGEL® (August 14, 2024)
  • K240097 — Polysaccharide Hemostatic Powder (HP-2, HP-3, HP-5) (May 22, 2024)
  • K232216 — Hemoblock_S (Prescription); Hemoblock_S (OTC) (April 19, 2024)
  • K240454 — RESPONDER® Polysaccharide Hemostat (March 15, 2024)
  • K220525 — RESPONDER Polysaccharide Hemostat (December 4, 2023)
  • K230589 — Celox Rapid X-Ray Gauze (November 17, 2023)
  • K213413 — Hemostatic Dressing (September 1, 2023)

FDA data resources