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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 / December 2025 / K251779

510(k) cleared

Omnipod 5 algorithm

Insulet Corporation · Dec 3, 2025 · K251779

FDA cleared the Omnipod 5 algorithm from Insulet Corporation on Dec 3, 2025 under K251779, 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 Jun 10, 2025. The decision came 176 days later, longer than the 90 FDA-day review goal, which usually means at least one additional information request.

Insulet Corporation has one other decision in the tracker over the last 12 months: K261461 (Omnipod 6 algorithm).

Questions & Answers

What did FDA clear under K251779?

K251779 is the FDA 510(k) for Omnipod 5 algorithm, submitted by Insulet Corporation. FDA's decision date was Dec 3, 2025, under product code QJI (Interoperable Automated Glycemic Controller).

Who makes the Omnipod 5 algorithm?

Insulet Corporation, based in Acton, MA, is the applicant of record for K251779.

How long did the K251779 review take?

FDA received the submission on Jun 10, 2025 and issued its decision on Dec 3, 2025, 176 days later.

← All decisions in December 2025

Sources