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510(k) K210714

Extended Reservoir by Medtronic Minimed, Inc. — Product Code LZG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 6, 2022
Date Received
March 10, 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 Medtronic Minimed, Inc.

  • K253743 — MiniMed Flex pump (March 12, 2026)
  • K253701 — SmartGuard Technology; Predictive Low Glucose Technology (February 3, 2026)
  • K253470 — MiniMed 780G Insulin Pump (MMT-1884); MiniMed 780G Insulin Pump Kit (MMT-1894) (January 15, 2026)
  • K253585 — SmartGuard technology; Predictive Low Glucose technology (January 14, 2026)
  • K253512 — MiniMed Go App (January 8, 2026)
  • K251217 — SmartGuard technology; Predictive Low Glucose technology (August 29, 2025)
  • K251032 — MiniMed 780G insulin pump (July 1, 2025)
  • K242775 — InPen System App (MMT-8060 (iOS), MMT-8061 (Android)) (November 12, 2024)
  • K241622 — Extended Reservoir; MiniMed Reservoir (July 2, 2024)
  • K160860 — MiniMed Quick-serter (September 22, 2016)

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)
  • 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)
  • K160056 — t:slim Insulin Delivery System (July 25, 2016)