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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 / December 2025 / K252508

510(k) cleared

Intri26 Introducer Sheath

Inari Medical, Inc. · Dec 17, 2025 · K252508

FDA cleared the Intri26 Introducer Sheath from Inari Medical, Inc. on Dec 17, 2025 under K252508, 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 Aug 8, 2025. The decision came 131 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Inari Medical, Inc. has one other decision in the tracker over the last 12 months: K253323 (Protrieve Sheath).

Questions & Answers

What did FDA clear under K252508?

K252508 is the FDA 510(k) for Intri26 Introducer Sheath, submitted by Inari Medical, Inc.. FDA's decision date was Dec 17, 2025, under product code DYB (Introducer, Catheter).

Who makes the Intri26 Introducer Sheath?

Inari Medical, Inc., based in Irvine, CA, is the applicant of record for K252508.

How long did the K252508 review take?

FDA received the submission on Aug 8, 2025 and issued its decision on Dec 17, 2025, 131 days later.

← All decisions in December 2025

Sources