WHERE ARE YOU?

Concept Pre-Sub Submission prep Newly cleared Raising Postmarket & security

THE TAPE

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 / October 2025 / K253323

510(k) cleared

Protrieve Sheath

Inari Medical · Oct 29, 2025 · K253323

FDA cleared the Protrieve Sheath from Inari Medical on Oct 29, 2025 under K253323, a special 510(k). The device falls under product code QEW, Peripheral Mechanical Thrombectomy With Aspiration, regulated at 21 CFR 870.5150 as a Class 2 device. The review panel was Cardiovascular.

FDA logged the submission as received on Sep 30, 2025. The decision came 29 days later, inside the 90 FDA-day goal for a 510(k).

Inari Medical has one other decision in the tracker over the last 12 months: K252508 (Intri26 Introducer Sheath).

Questions & Answers

What did FDA clear under K253323?

K253323 is the FDA 510(k) for Protrieve Sheath, submitted by Inari Medical. FDA's decision date was Oct 29, 2025, under product code QEW (Peripheral Mechanical Thrombectomy With Aspiration).

Who makes the Protrieve Sheath?

Inari Medical, based in Irvine, CA, is the applicant of record for K253323.

How long did the K253323 review take?

FDA received the submission on Sep 30, 2025 and issued its decision on Oct 29, 2025, 29 days later.

← All decisions in October 2025

Sources