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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 / April 2026 / K252757

510(k) cleared

CeQur Simplicity On-Demand Insulin Delivery System

Cequr SA · Apr 10, 2026 · K252757

FDA cleared the CeQur Simplicity On-Demand Insulin Delivery System from Cequr SA on Apr 10, 2026 under K252757, a special 510(k). The device falls under product code OPP, Pump, Infusion, Insulin Bolus, regulated at 21 CFR 880.5725 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on Aug 29, 2025. The decision came 224 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

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

Questions & Answers

What did FDA clear under K252757?

K252757 is the FDA 510(k) for CeQur Simplicity On-Demand Insulin Delivery System, submitted by Cequr SA. FDA's decision date was Apr 10, 2026, under product code OPP (Pump, Infusion, Insulin Bolus).

Who makes the CeQur Simplicity On-Demand Insulin Delivery System?

Cequr SA, based in Horw Luzern, is the applicant of record for K252757.

How long did the K252757 review take?

FDA received the submission on Aug 29, 2025 and issued its decision on Apr 10, 2026, 224 days later.

← All decisions in April 2026