Cleared Special

K252757 - CeQur Simplicity™ On-Demand Insulin Delivery System (FDA 510(k) Clearance)

Class II Chemistry device cleared through the Special 510(k) pathway - typically does not require clinical trials.

K252757 · Cequr SA · Chemistry device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 2026
Decision
224d
Days
Class 2
Risk

K252757 is an FDA 510(k) clearance for the CeQur Simplicity™ On-Demand Insulin Delivery System. Classified as Pump, Infusion, Insulin Bolus (product code OPP), Class II - Special Controls.

Submitted by Cequr SA (Horw Luzern, CH). The FDA issued a Cleared decision on April 10, 2026 after a review of 224 days - an extended review cycle.

This device falls under the Chemistry FDA review panel, regulated under 21 CFR 880.5725 - the FDA in vitro diagnostics and chemistry framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Cequr SA devices

Submission Details

510(k) Number K252757 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 29, 2025
Decision Date April 10, 2026
Days to Decision 224 days
Submission Type Special
Review Panel Chemistry (CH)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
136d slower than avg
Panel avg: 88d · This submission: 224d
Pathway characteristics
Modification to existing cleared device.

Device Classification

Product Code OPP Pump, Infusion, Insulin Bolus
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 880.5725
Definition The Device Is Adhered To The Body For Several Days For The Purpose Of Periodically Infusing An Insulin Bolus.
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Chemistry devices follow this clearance model.