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FDA 510(k)

CeQur Simplicity™ On-Demand Insulin Delivery System

K-Number: K252757 · 2026-04-10

ApplicantCequr SA
Decision Date2026-04-10
Product CodeOPP
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

CeQur Simplicity™ On-Demand Insulin Delivery System is a medical device manufactured by Cequr SA. It received FDA 510(k) clearance on 2026-04-10 under approval number K252757. The device is classified under product code OPP. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CeQur Simplicity™ On-Demand Insulin Delivery System?

CeQur Simplicity™ On-Demand Insulin Delivery System is a medical device that received FDA 510(k) clearance on 2026-04-10. It is manufactured by Cequr SA. The 510(k) number is K252757.

When was CeQur Simplicity™ On-Demand Insulin Delivery System approved by the FDA?

CeQur Simplicity™ On-Demand Insulin Delivery System received FDA 510(k) clearance on 2026-04-10, under approval number K252757.

What company makes CeQur Simplicity™ On-Demand Insulin Delivery System?

CeQur Simplicity™ On-Demand Insulin Delivery System is manufactured by Cequr SA.

What is the FDA product code for CeQur Simplicity™ On-Demand Insulin Delivery System?

The FDA product code for CeQur Simplicity™ On-Demand Insulin Delivery System is OPP.

Related Clinical Trials

NCT07039942 French Prospective Multicentric Study in Real World RECRUITING NCT07611721 Evaluate the Performance of the Dexcom G7 Continuous Glucose Monitoring (CGM) System in Critically Ill Patients Undergoing Major Abdominal Surgery and Solid Organ Transplantation Which Require Blood Glucose Monitoring for Intensive Insulin Therapy. RECRUITING NCT06728059 Safety and Feasibility of a Machine-Learning Bolus Priming Added to Existing Control Algorithm COMPLETED NCT07458243 A Prospective, Multicenter, Single Arm Registry of ENROUTE NPS in Conjunction With Carotid WALLSTENT in Chinese Population NOT_YET_RECRUITING NCT07430293 Hybrid Closed-Loop Insulin Delivery After Pancreatectomy RECRUITING NCT04414280 The Impact of Hybrid Closed-loop Insulin Delivery in Type 1 Diabetes on Glycemic Control and PROMs ACTIVE_NOT_RECRUITING

Related PubMed Literature

PMID: 40965839 A multi-stakeholder perspective on medical devices for children and adolescents with type 1 diabetes: huge unmet needs for the smallest. Journal of pediatric endocrinology & metabolism : JPEM (2025)

Other Devices by Cequr SA

K243273CeQur Simplicity™ On-Demand Insulin Delivery System K233447CeQur Simplicity™ On-Demand Insulin Delivery System

Related Devices (Code: OPP)

K163357OneTouch Via On-Demand Insulin Delivery SystemLifescan Europe, A Division of Cilag GmbH K243273CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA K233447CeQur Simplicity™ On-Demand Insulin Delivery SystemCequr SA

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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