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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 the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2023-10-18 under 510(k) 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. The listed applicant is Insulet Corporation. The 510(k) number is K231826.

When did Omnipod 5 ACE Pump receive FDA 510(k) clearance?

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

Who is the listed applicant for Omnipod 5 ACE Pump?

The FDA 510(k) record lists Insulet Corporation as the applicant. This does not by itself establish the device manufacturer.

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

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

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT06144554Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 DiabetesRECRUITINGNCT07039942French Prospective Multicentric Study in Real WorldACTIVE_NOT_RECRUITINGNCT07039981Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 DiabetesCOMPLETEDNCT07317102Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)RECRUITINGNCT07521475Evaluation of the Fully Closed Loop Omnipod® System in Type 2 DiabetesRECRUITINGNCT07579702Efficacy of the Omnipod® 6 System Compared With the Omnipod® 5 SystemRECRUITING

Other records listing Insulet Corporation as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261461Omnipod 6 algorithmK251779Omnipod 5 algorithmK241777SmartAdjust™ TechnologyK232741SmartAdjust(TM) technologyK231824SmartBolus CalculatorK223372Omnipod GO Insulin Delivery Device

View all 19 devices →

Related Devices (Code: QFG)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K261672twiist Automated Insulin Delivery (AID) SystemDeka Research and DevelopmentK253976iLet ACE PumpBeta Bionics, Inc.K253743MiniMed Flex pumpMedtronic Minimed, Inc.K253470MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894)Medtronic Minimed, Inc.K253074Tandem Mobi insulin pump with interoperable technologyTandem Diabetes Care, Inc.K252770iLet ACE PumpBeta Bionics, Inc.

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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