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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 / K261461

510(k) cleared

Omnipod 6 algorithm

Insulet Corporation · Jun 29, 2026 · K261461

FDA cleared the Omnipod 6 algorithm from Insulet Corporation on Jun 29, 2026 under K261461, a traditional 510(k). The device falls under product code QJI, Interoperable Automated Glycemic Controller, regulated at 21 CFR 862.1356 as a Class 2 device. The review panel was Clinical Chemistry.

FDA logged the submission as received on May 4, 2026. The decision came 56 days later, inside the 90 FDA-day goal for a 510(k).

Insulet Corporation has one other decision in the tracker over the last 12 months: K251779 (Omnipod 5 algorithm).

Questions & Answers

What did FDA clear under K261461?

K261461 is the FDA 510(k) for Omnipod 6 algorithm, submitted by Insulet Corporation. FDA's decision date was Jun 29, 2026, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the Omnipod 6 algorithm?

Insulet Corporation, based in Acton, MA, is the applicant of record for K261461.

How long did the K261461 review take?

FDA received the submission on May 4, 2026 and issued its decision on Jun 29, 2026, 56 days later.

← All decisions in June 2026

Sources