Omnipod 5 algorithm
K-Number: K251779 · 2025-12-03
ApplicantInsulet Corporation
Decision Date2025-12-03
Product CodeQJI
Advisory CommitteeCH
DecisionSubstantially Equivalent
Device Summary
Omnipod 5 algorithm is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2025-12-03 under approval number K251779. The device is classified under product code QJI. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Omnipod 5 algorithm?
Omnipod 5 algorithm is a medical device that received FDA 510(k) clearance on 2025-12-03. It is manufactured by Insulet Corporation. The 510(k) number is K251779.
When was Omnipod 5 algorithm approved by the FDA?
Omnipod 5 algorithm received FDA 510(k) clearance on 2025-12-03, under approval number K251779.
What company makes Omnipod 5 algorithm?
Omnipod 5 algorithm is manufactured by Insulet Corporation.
What is the FDA product code for Omnipod 5 algorithm?
The FDA product code for Omnipod 5 algorithm is QJI.
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Official Source
View on FDA Database →Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.