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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 / K261672

510(k) cleared

twiist Automated Insulin Delivery (AID) System

Deka Research and Development · Jun 17, 2026 · K261672

FDA cleared the twiist Automated Insulin Delivery (AID) System from Deka Research and Development on Jun 17, 2026 under K261672, a special 510(k). The device falls under product code QFG, Alternate Controller Enabled Insulin Infusion Pump, regulated at 21 CFR 880.5730 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on May 21, 2026. The decision came 27 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: K261530 (iiSure Infusion Set).

Questions & Answers

What did FDA clear under K261672?

K261672 is the FDA 510(k) for twiist Automated Insulin Delivery (AID) System, submitted by Deka Research and Development. FDA's decision date was Jun 17, 2026, under product code QFG (Alternate Controller Enabled Insulin Infusion Pump).

Who makes the twiist Automated Insulin Delivery (AID) System?

Deka Research and Development, based in Manchester, NH, is the applicant of record for K261672.

How long did the K261672 review take?

FDA received the submission on May 21, 2026 and issued its decision on Jun 17, 2026, 27 days later.

← All decisions in June 2026

Sources