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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 / November 2025 / K253290

510(k) cleared

XSTAT P15

Revmedx, Inc. · Nov 12, 2025 · K253290

FDA cleared the XSTAT P15 from Revmedx, Inc. on Nov 12, 2025 under K253290, a traditional 510(k). The device falls under product code PGZ, Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use, regulated at 21 CFR 878.4452 as a Class 2 device. The review panel was General, Plastic Surgery.

FDA logged the submission as received on Sep 29, 2025. The decision came 44 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253290?

K253290 is the FDA 510(k) for XSTAT P15, submitted by Revmedx, Inc.. FDA's decision date was Nov 12, 2025, under product code PGZ (Non-Absorbable, Expandable, Hemostatic Sponge For Temporary Internal Use).

Who makes the XSTAT P15?

Revmedx, Inc., based in Wilsonville, OR, is the applicant of record for K253290.

How long did the K253290 review take?

FDA received the submission on Sep 29, 2025 and issued its decision on Nov 12, 2025, 44 days later.

← All decisions in November 2025