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FDA 510(k)

Omnipod Insulin Management System, Omnipod DASH Insulin Management System

K-Number: K182630 · 2019-01-08

ApplicantInsulet Corporation
Decision Date2019-01-08
Product CodeLZG
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Omnipod Insulin Management System, Omnipod DASH Insulin Management System is a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2019-01-08 under approval number K182630. 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 DASH Insulin Management System?

Omnipod Insulin Management System, Omnipod DASH Insulin Management System is a medical device that received FDA 510(k) clearance on 2019-01-08. It is manufactured by Insulet Corporation. The 510(k) number is K182630.

When was Omnipod Insulin Management System, Omnipod DASH Insulin Management System approved by the FDA?

Omnipod Insulin Management System, Omnipod DASH Insulin Management System received FDA 510(k) clearance on 2019-01-08, under approval number K182630.

What company makes Omnipod Insulin Management System, Omnipod DASH Insulin Management System?

Omnipod Insulin Management System, Omnipod DASH Insulin Management System is manufactured by Insulet Corporation.

What is the FDA product code for Omnipod Insulin Management System, Omnipod DASH Insulin Management System?

The FDA product code for Omnipod Insulin Management System, Omnipod DASH Insulin Management System is LZG.

Related Clinical Trials

NCT06011187 Assisted Fluid Management (AFM) System and Postoperative Outcome After High-risk Abdominal Surgery COMPLETED NCT05701917 DEFIANCE: RCT of ClotTriever System Versus Anticoagulation In Deep Vein Thrombosis RECRUITING NCT05174312 Fluid Management of Acute Decompensated Heart Failure Subjects Treated With Reprieve Decongestion Management System (DMS) COMPLETED NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED

Related PubMed Literature

PMID: 32459382 Safety Assessment of an A-Scan Ultrasonic System for Ophthalmic Use. Journal of ultrasound in medicine : official journal of the American Institute of Ultrasound in Medicine (2020)

Other Devices by Insulet Corporation

K160252OmniPod Insulin Management System K162296OmniPod Insulin Management System K180045Omnipod DASH Insulin Management System K192659Omnipod Insulin Management System, Omnipod DASH Insulin Management System K191679Omnipod DASH Insulin Management System with interoperable technology K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System

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Related Devices (Code: LZG)

K162080t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160056t:slim Insulin Delivery SystemTandem Diabetes Care, Inc. K160482t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device UpdaterTandem Diabetes Care, Inc. K160252OmniPod Insulin Management SystemInsulet Corporation K162296OmniPod Insulin Management SystemInsulet Corporation K180045Omnipod 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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