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FDA 510(k)

Omnipod 5 ACE Pump (Pod)

K-Number: K203768 · 2022-01-27

ApplicantInsulet Corporation
Decision Date2022-01-27
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Omnipod 5 ACE Pump (Pod) is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2022-01-27 under approval number K203768. 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 (Pod)?

Omnipod 5 ACE Pump (Pod) is a medical device that received FDA 510(k) clearance on 2022-01-27. It is manufactured by Insulet Corporation. The 510(k) number is K203768.

When was Omnipod 5 ACE Pump (Pod) approved by the FDA?

Omnipod 5 ACE Pump (Pod) received FDA 510(k) clearance on 2022-01-27, under approval number K203768.

What company makes Omnipod 5 ACE Pump (Pod)?

Omnipod 5 ACE Pump (Pod) is manufactured by Insulet Corporation.

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

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

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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.

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