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FDA 510(k)

Omnipod 5 ACE Pump

K-Number: K231826 · 2023-10-18

ApplicantInsulet Corporation
Decision Date2023-10-18
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Omnipod 5 ACE Pump is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2023-10-18 under approval number K231826. The device is classified under product code QFG. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnipod 5 ACE Pump?

Omnipod 5 ACE Pump is a medical device that received FDA 510(k) clearance on 2023-10-18. It is manufactured by Insulet Corporation. The 510(k) number is K231826.

When was Omnipod 5 ACE Pump approved by the FDA?

Omnipod 5 ACE Pump received FDA 510(k) clearance on 2023-10-18, under approval number K231826.

What company makes Omnipod 5 ACE Pump?

Omnipod 5 ACE Pump is manufactured by Insulet Corporation.

What is the FDA product code for Omnipod 5 ACE Pump?

The FDA product code for Omnipod 5 ACE Pump is QFG.

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Related Devices (Code: QFG)

K191679Omnipod DASH Insulin Management System with interoperable technologyInsulet Corporation DEN180058t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation K230545Inessa SystemTriple Jump Israel , Ltd.

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.

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