Omnipod DASH Insulin Management System with interoperable technology
FDA 510(k) K191679 · Insulet Corporation
Submission
- Device name
- Omnipod DASH Insulin Management System with interoperable technology
- Applicant
- Insulet Corporation
Acton, MA, US - Received
- June 24, 2019
- Decision date
- September 20, 2019
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- QFG – Alternate Controller Enabled Insulin Infusion Pump
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 880.5730
- Specialty
- Clinical Chemistry
An alternate controller enabled insulin infusion pump (ACE insulin pump) is a device intended for the infusion of insulin into a patient. The ACE insulin pump may include basal and bolus drug delivery at set or variable rates. ACE insulin pumps are designed to reliably and securely communicate with external devices, such as automated insulin dosing systems, to allow insulin delivery commands to…
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Questions and answers
When was Omnipod DASH Insulin Management System with interoperable technology cleared by the FDA?
Omnipod DASH Insulin Management System with interoperable technology (K191679) received a 510(k) decision of Substantially Equivalent on September 20, 2019, 88 days after the submission was received.
What is the product code of K191679?
The FDA product code is QFG – Alternate Controller Enabled Insulin Infusion Pump, a Class II (moderate risk) device regulated under 21 CFR 880.5730.