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510(k) K252757

CeQur Simplicity™ On-Demand Insulin Delivery System by Cequr SA — Product Code OPP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 10, 2026
Date Received
August 29, 2025
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

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

The device is adhered to the body for several days for the purpose of periodically infusing an insulin bolus.

Other clearances by Cequr SA

  • K243273 — CeQur Simplicity™ On-Demand Insulin Delivery System (November 13, 2024)
  • K233447 — CeQur Simplicity™ On-Demand Insulin Delivery System (January 18, 2024)

Other clearances for product code OPP

  • K243273 — CeQur Simplicity™ On-Demand Insulin Delivery System (November 13, 2024)
  • K233447 — CeQur Simplicity™ On-Demand Insulin Delivery System (January 18, 2024)
  • K163357 — OneTouch Via On-Demand Insulin Delivery System (June 7, 2017)
  • K111924 — FINESSE PERSONAL INSULIN DELIVERY PATCH (April 10, 2012)
  • K100947 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 (June 28, 2010)
  • K093065 — FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 (January 20, 2010)