Cleared Special

K252757 - CeQur Simplicity™ On-Demand Insulin Delivery System

K252757 is an FDA 510(k) clearance for CeQur Simplicity On-Demand Insulin Deli..., manufactured by Cequr SA. The device is a Class 2 Chemistry device with product code OPP cleared through the Special 510(k) pathway after a 224-day FDA review.

K252757 · Cequr SA · Chemistry device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K252757

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
135d slower than avg
Panel avg: 89d · This submission: 224d
Pathway characteristics
Modification to existing cleared device.

OPP Device Classification - Class 2, Special Controls

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.

Regulatory Peers - OPP Pump, Infusion, Insulin Bolus

Devices cleared under the same product code (OPP) and FDA review panel - the closest regulatory comparables to K252757.
CeQur Simplicity™ On-Demand Insulin Delivery System
K243273 · Cequr SA · Nov 2024
CeQur Simplicity™ On-Demand Insulin Delivery System
K233447 · Cequr SA · Jan 2024
OneTouch Via On-Demand Insulin Delivery System
K163357 · Lifescan Europe, A Division of Cilag GmbH · Jun 2017
FINESSE PERSONAL INSULIN DELIVERY PATCH
K111924 · Calibra Medical, Inc. · Apr 2012
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000
K100947 · Calibra Medical, Inc. · Jun 2010
FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000
K093065 · Calibra Medical, Inc. · Jan 2010
K252757 · CeQur Simplicity™ On-Demand Insulin Delivery System
Download PDF FDA Summary Cequr SA