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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 the device name listed in this FDA 510(k) record. The listed applicant is Cequr SA. It received FDA 510(k) clearance on 2026-04-10 under 510(k) 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. The listed applicant is Cequr SA. The 510(k) number is K252757.

When did CeQur Simplicity™ On-Demand Insulin Delivery System receive FDA 510(k) clearance?

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

Who is the listed applicant for CeQur Simplicity™ On-Demand Insulin Delivery System?

The FDA 510(k) record lists Cequr SA as the applicant. This does not by itself establish the device manufacturer.

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.

Other records listing Cequr SA as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Related Devices (Code: OPP)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

Official Source

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