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510(k) K180045

Omnipod DASH Insulin Management System by Insulet Corporation — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 1, 2018
Date Received
January 8, 2018
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Pump, Infusion, Insulin
Device Class
Class II
Regulation Number
880.5725
Review Panel
CH
Submission Type

Other clearances by Insulet Corporation

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  • K231824 — SmartBolus Calculator (October 18, 2023)
  • K231826 — Omnipod 5 ACE Pump (October 18, 2023)
  • K223372 — Omnipod GO Insulin Delivery Device (April 24, 2023)
  • K220394 — SmartAdjust(TM) technology (August 19, 2022)
  • K222239 — SmartBolus Calculator (August 19, 2022)
  • K203772 — Omnipod 5 SmartBolus Calculator (January 27, 2022)
  • K203768 — Omnipod 5 ACE Pump (Pod) (January 27, 2022)

Other clearances for product code LZG

  • K240158 — Modular Medical MODD1 Insulin Delivery System (September 4, 2024)
  • K241622 — Extended Reservoir; MiniMed Reservoir (July 2, 2024)
  • K223372 — Omnipod GO Insulin Delivery Device (April 24, 2023)
  • K210714 — Extended Reservoir (April 6, 2022)
  • K211575 — Omnipod® Insulin Management System, Omnipod DASH® Insulin Management System (August 13, 2021)
  • K192659 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (October 21, 2019)
  • K182630 — Omnipod Insulin Management System, Omnipod DASH Insulin Management System (January 8, 2019)
  • K162296 — OmniPod Insulin Management System (April 18, 2017)
  • K162080 — t:slim Insulin Delivery System, t:flex Insulin Delivery System, Tandem Device Up (October 25, 2016)
  • K160056 — t:slim Insulin Delivery System (July 25, 2016)