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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 / February 2026 / K253791

510(k) cleared

PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid

DePuy Mitek, Inc. · Feb 26, 2026 · K253791

FDA cleared the PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid from DePuy Mitek, Inc. on Feb 26, 2026 under K253791, a traditional 510(k). The device falls under product code KCT, Sterilization Wrap Containers, Trays, Cassettes & Other Accessories, regulated at 21 CFR 880.6850 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Nov 28, 2025. The decision came 90 days later, inside the 90 FDA-day goal for a 510(k).

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

Questions & Answers

What did FDA clear under K253791?

K253791 is the FDA 510(k) for PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid, submitted by DePuy Mitek, Inc.. FDA's decision date was Feb 26, 2026, under product code KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories).

Who makes the PUREVUE Quick Connect Cannula System Tray; PUREVUE Quick Connect Cannula System Lid?

DePuy Mitek, Inc., based in Raynham, MA, is the applicant of record for K253791.

How long did the K253791 review take?

FDA received the submission on Nov 28, 2025 and issued its decision on Feb 26, 2026, 90 days later.

← All decisions in February 2026