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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 / K261530

510(k) cleared

iiSure Infusion Set

Deka Research and Development · Jun 3, 2026 · K261530

FDA cleared the iiSure Infusion Set from Deka Research and Development on Jun 3, 2026 under K261530, a special 510(k). The device falls under product code FPA, Set, Administration, Intravascular, regulated at 21 CFR 880.5440 as a Class 2 device. The review panel was General Hospital.

FDA logged the submission as received on May 8, 2026. The decision came 26 days later, inside the 90 FDA-day goal for a 510(k).

Deka Research and Development has one other decision in the tracker over the last 12 months: K261672 (twiist Automated Insulin Delivery (AID) System).

Questions & Answers

What did FDA clear under K261530?

K261530 is the FDA 510(k) for iiSure Infusion Set, submitted by Deka Research and Development. FDA's decision date was Jun 3, 2026, under product code FPA (Set, Administration, Intravascular).

Who makes the iiSure Infusion Set?

Deka Research and Development, based in Manchester, NH, is the applicant of record for K261530.

How long did the K261530 review take?

FDA received the submission on May 8, 2026 and issued its decision on Jun 3, 2026, 26 days later.

← All decisions in June 2026

Sources