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FDA 510(k)

Omnipod DASH Insulin Management System with interoperable technology

K-Number: K191679 · 2019-09-20

ApplicantInsulet Corporation
Decision Date2019-09-20
Product CodeQFG
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

Omnipod DASH Insulin Management System with interoperable technology is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2019-09-20 under 510(k) number K191679. 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 DASH Insulin Management System with interoperable technology?

Omnipod DASH Insulin Management System with interoperable technology is a medical device that received FDA 510(k) clearance on 2019-09-20. The listed applicant is Insulet Corporation. The 510(k) number is K191679.

When did Omnipod DASH Insulin Management System with interoperable technology receive FDA 510(k) clearance?

Omnipod DASH Insulin Management System with interoperable technology received FDA 510(k) clearance on 2019-09-20, under 510(k) number K191679.

Who is the listed applicant for Omnipod DASH Insulin Management System with interoperable technology?

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 DASH Insulin Management System with interoperable technology?

The FDA product code for Omnipod DASH Insulin Management System with interoperable technology 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.

NCT07039942French Prospective Multicentric Study in Real WorldACTIVE_NOT_RECRUITINGNCT07317102Omnipod-5 A French Prospective Multicentric Study in Real World (Optimal-B)RECRUITINGNCT07521475Evaluation of the Fully Closed Loop Omnipod® System in Type 2 DiabetesRECRUITINGNCT07593625Evaluating Glucose Control Using a Next-Generation AID Algorithm in Individuals With T1DRECRUITINGNCT06144554Post Market Registry for the Omnipod 5 System in Children and Adults With Type 1 DiabetesRECRUITINGNCT07039981Evaluating Glucose Control Using a Next Generation Automated Insulin Delivery Algorithm in Adults With Type 2 DiabetesCOMPLETED

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) technologyK231826Omnipod 5 ACE PumpK231824SmartBolus Calculator

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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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