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Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register Elucid raises $55M Series D with FFR-CT 510(k) under FDA review Enovis to buy eCential Robotics for 155 million euros FDA authorizes Vitestro's Aletta, the first autonomous blood-drawing robot, five months after a $70M Series B Renata Medical raises $25M Series D to scale the Minima pediatric stent FDA opens a docket on how to regulate generative AI devices FDA clears Jupiter Endovascular's Vertex thrombectomy system for pulmonary embolism in 89 days FDA clears Wandercraft's Eve, the first self-balancing exoskeleton for home use Meduloc raises $4M Series B to start alpha launch of its nitinol fracture implant FDA sets FY2027 device user fees: $28,653 for a 510(k), $13,785 to register

The Tracker / April 2026 / K253017

510(k) cleared

BloodSTOP iX Trauma Matrix (TM-iX-20)

Lifescience Plus, Inc. · Apr 30, 2026 · K253017

FDA cleared the BloodSTOP iX Trauma Matrix (TM-iX-20) from Lifescience Plus, Inc. on Apr 30, 2026 under K253017, a traditional 510(k). The device falls under product code QSY, Hemostatic Wound Dressing Without Thrombin Or Other Biologics as a Class U device. The review panel was Unknown.

FDA logged the submission as received on Sep 19, 2025. The decision came 223 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

This is the only decision on file for Lifescience Plus, Inc. in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253017?

K253017 is the FDA 510(k) for BloodSTOP iX Trauma Matrix (TM-iX-20), submitted by Lifescience Plus, Inc.. FDA's decision date was Apr 30, 2026, under product code QSY (Hemostatic Wound Dressing Without Thrombin Or Other Biologics).

Who makes the BloodSTOP iX Trauma Matrix (TM-iX-20)?

Lifescience Plus, Inc., based in Mountain View, CA, is the applicant of record for K253017.

How long did the K253017 review take?

FDA received the submission on Sep 19, 2025 and issued its decision on Apr 30, 2026, 223 days later.

← All decisions in April 2026