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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 / January 2026 / K253652

510(k) cleared

Genie MAX Large Bore Introducer Sheath

Cultiv8 1, LLC · Jan 22, 2026 · K253652

FDA cleared the Genie MAX Large Bore Introducer Sheath from Cultiv8 1, LLC on Jan 22, 2026 under K253652, a traditional 510(k). The device falls under product code DYB, Introducer, Catheter, regulated at 21 CFR 870.1340 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Nov 20, 2025. The decision came 63 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Cultiv8 1, LLC in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K253652?

K253652 is the FDA 510(k) for Genie MAX Large Bore Introducer Sheath, submitted by Cultiv8 1, LLC. FDA's decision date was Jan 22, 2026, under product code DYB (Introducer, Catheter).

Who makes the Genie MAX Large Bore Introducer Sheath?

Cultiv8 1, LLC, based in Plymouth, MN, is the applicant of record for K253652.

How long did the K253652 review take?

FDA received the submission on Nov 20, 2025 and issued its decision on Jan 22, 2026, 63 days later.

← All decisions in January 2026