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510(k) K143189

t:flex Insulin Delivery System by Tandem Diabetes Care, Inc. — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 9, 2015
Date Received
November 5, 2014
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 Tandem Diabetes Care, Inc.

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  • K251854 — SteadiSet infusion set (August 6, 2025)
  • K250798 — Control-IQ+ technology (May 21, 2025)
  • K243823 — Control-IQ+ technology (February 24, 2025)
  • K241078 — Tandem Mobi Insulin Pump with interoperable technology (July 26, 2024)
  • K240309 — Tandem Mobi insulin pump with interoperable technology (March 21, 2024)
  • K232380 — t:slim X2 Insulin Pump with Interoperable Technology (November 3, 2023)
  • K232382 — Control-IQ Technology (November 3, 2023)
  • K233044 — Tandem Mobi insulin pump with interoperable technology (October 5, 2023)

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)
  • 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)