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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 / June 2026 / K261242

510(k) cleared

SimplGuide

Pendracare · Jun 25, 2026 · K261242

FDA cleared the SimplGuide from Pendracare on Jun 25, 2026 under K261242, 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 Apr 15, 2026. The decision came 71 days later, inside the 90 FDA-day goal for a 510(k).

This is the only decision on file for Pendracare in the last 12 months of the tracker.

Questions & Answers

What did FDA clear under K261242?

K261242 is the FDA 510(k) for SimplGuide, submitted by Pendracare. FDA's decision date was Jun 25, 2026, under product code DYB (Introducer, Catheter).

Who makes the SimplGuide?

Pendracare, based in Leek, is the applicant of record for K261242.

How long did the K261242 review take?

FDA received the submission on Apr 15, 2026 and issued its decision on Jun 25, 2026, 71 days later.

← All decisions in June 2026