DeviceClearance

CeQur Simplicity On-Demand Insulin Delivery System— 510(k) K252757

Substantially Equivalent

Cequr SA

FDA 510(k) clearance K252757 for CeQur Simplicity On-Demand Insulin Delivery System, Substantially Equivalent on 2026-04-10. Applicant: Cequr SA. Device class: 2.

Summary

The CeQur Simplicity On-Demand Insulin Delivery System is filed under OPP, bolus insulin infusion pumps. The code covers devices adhered to the body for several days to periodically infuse an insulin bolus.

Class II, 21 CFR 880.5725, filed as a Special 510(k). The record lists General Hospital as the advisory panel and Clinical Chemistry as the review panel.

Cequr SA filed from Switzerland, with the city given as Horw Luzern. The review took 224 days (August 29, 2025 to April 10, 2026).

Clearance details

Applicant
Cequr SA
Product code
Product code OPP
Device class
Class 2
Regulation
21 CFR 880.5725
Advisory panel
General Hospital
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Special
Location
Horw Luzern, CH
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Data sourced from openFDA. This site is unofficial and independent of the FDA.