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FDA 510(k)

OmniPod Insulin Management System

K-Number: K160252 · 2016-04-27

ApplicantInsulet Corporation
Decision Date2016-04-27
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

OmniPod Insulin Management System is the device name listed in this FDA 510(k) record. The listed applicant is Insulet Corporation. It received FDA 510(k) clearance on 2016-04-27 under 510(k) number K160252. The device is classified under product code LZG. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OmniPod Insulin Management System?

OmniPod Insulin Management System is a medical device that received FDA 510(k) clearance on 2016-04-27. The listed applicant is Insulet Corporation. The 510(k) number is K160252.

When did OmniPod Insulin Management System receive FDA 510(k) clearance?

OmniPod Insulin Management System received FDA 510(k) clearance on 2016-04-27, under 510(k) number K160252.

Who is the listed applicant for OmniPod Insulin Management System?

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 Insulin Management System?

The FDA product code for OmniPod Insulin Management System is LZG.

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.

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Related Devices (Code: LZG)

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.

K253534Pivot Insulin Delivery SystemModular MedicalK240158Modular Medical MODD1 Insulin Delivery SystemModular Medical, Inc.K241622Extended Reservoir; MiniMed ReservoirMedtronic MinimedK223372Omnipod GO Insulin Delivery DeviceInsulet CorporationK210714Extended ReservoirMedtronic Minimed, Inc.K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management SystemInsulet Corporation

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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