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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 a medical device manufactured by Insulet Corporation. It received FDA 510(k) clearance on 2019-09-20 under approval 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. It is manufactured by Insulet Corporation. The 510(k) number is K191679.

When was Omnipod DASH Insulin Management System with interoperable technology approved by the FDA?

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

What company makes Omnipod DASH Insulin Management System with interoperable technology?

Omnipod DASH Insulin Management System with interoperable technology is manufactured by Insulet Corporation.

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

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: 41964171 Journal of diabetes science and technology (2026) PMID: 41887630 Capacity building for ethical use of artificial intelligence in health: protocol for a scoping review of training initiatives and gaps in Africa. BMJ open (2026) PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025) PMID: 41054198 Relevant domains for health technology assessment of medical device reimbursement in Brazil's unified health system: a survey and Delphi panel study on stakeholder preferences. International journal of technology assessment in health care (2025)

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 K182630Omnipod Insulin Management System, Omnipod DASH Insulin Management System K211575Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System

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Related Devices (Code: QFG)

DEN180058t:slim X2 insulin pump with interoperable technologyTandem Diabetes Care, Inc. K201214t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, Inc. K203234t:slim X2 Insulin Pump with Interoperable Technology (with t:connect mobile app)Tandem Diabetes Care, Inc. K203768Omnipod 5 ACE Pump (Pod)Insulet Corporation K230545Inessa SystemTriple Jump Israel , Ltd. K232380t:slim X2 Insulin Pump with Interoperable TechnologyTandem Diabetes Care, 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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