On June 29, 2026, the FDA cleared the Omnipod 6 algorithm from Insulet Corporation, the software that decides how much insulin an Omnipod 6 pod delivers when the system runs on its own.[1] The clearance number is K261461. The FDA received Insulet's application on May 4, 2026, and the FDA found the software "substantially equivalent" to an earlier device.[2]
What the FDA cleared
The cleared product is software only. The FDA classifies it as an interoperable automated glycemic controller, a Class II device type for algorithms that can work with separately made sensors and pumps.[1] According to the 510(k) summary, the algorithm takes readings from a compatible integrated CGM (iCGM) and sends dosing commands to a compatible alternate controller enabled (ACE) pump. It can increase, decrease or pause insulin based on current and predicted glucose.[1]
The indications cover two groups: people with type 1 diabetes aged 2 and older, and adults 18 and older with type 2 diabetes. The software requires a prescription and is meant for a single patient.[1] The summary lists the insulins the system was tested with as NovoLog, Humalog, Admelog and Kirsty, all U-100.[1]
How it differs from the Omnipod 5 algorithm
The predicate, the earlier device Insulet compared against, was the Omnipod 5 algorithm (K251779).[1] The summary describes the intended use as identical apart from the name.[1] The main change it names is the "adaptive rate." In Omnipod 5 that rate adjusted to a user's insulin history; in Omnipod 6 it also accounts for the user's bolus behavior.[1]
Here is what we found most concrete in the filing. The algorithm calculates a small automatic correction dose every 5 minutes, looking 60 minutes ahead at predicted glucose.[1] Users can set a glucose target between 100 and 150 mg/dL, and an Activity feature raises the target to 150 mg/dL for up to 24 hours.[1] If the pod gets no CGM data for 20 minutes or more, the system switches to a limited mode. There, basal delivery stays at or below the lower of the programmed basal rate and a rate based on past insulin use, until readings return.[1]
The summary says the algorithm runs on both the Omnipod 6 Pod and the Omnipod 6 App, which can sit on a compatible smartphone or on an Insulet-provided controller.[1] It describes the full Omnipod 6 system as three regulated devices: this algorithm, the Omnipod 6 ACE Pump and the SmartBolus Calculator. K261461 covers only the algorithm, and we did not check the status of the other two.[1]
The STRIVE study
Insulet's pivotal study, called STRIVE, was a randomized crossover trial in 132 participants: 98 with type 1 diabetes (ages 2 to 70) and 34 with type 2 diabetes (ages 18 to 70).[1] Each person used Omnipod 6 and Omnipod 5 for 4 weeks apiece. The summary reports that Omnipod 6 met all primary safety endpoints, showing it was not worse than Omnipod 5 on time below 54 and 70 mg/dL, time in range and mean glucose.[1] It reports no severe hypoglycemia, diabetic ketoacidosis or deaths.[1]
What this means for you
The FDA record does not give a launch date, and we did not find an Insulet announcement with one.[2] The summary says the software requires a prescription.[1] Whether this system fits your diabetes care is a question to talk over with your care team or pharmacist.