Home / 510(k) Clearances / K211575

510(k) K211575

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

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 13, 2021
Date Received
May 21, 2021
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

  • K251779 — Omnipod 5 algorithm (December 3, 2025)
  • K241777 — SmartAdjust™ Technology (August 26, 2024)
  • K232741 — SmartAdjust(TM) technology (May 29, 2024)
  • K231824 — SmartBolus Calculator (October 18, 2023)
  • K231826 — Omnipod 5 ACE Pump (October 18, 2023)
  • K223372 — Omnipod GO Insulin Delivery Device (April 24, 2023)
  • K222239 — SmartBolus Calculator (August 19, 2022)
  • K220394 — SmartAdjust(TM) technology (August 19, 2022)
  • K203772 — Omnipod 5 SmartBolus Calculator (January 27, 2022)
  • K203774 — SmartAdjust technology (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)
  • 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)
  • K180045 — Omnipod DASH Insulin Management System (June 1, 2018)
  • 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)