← Product Code [OPP](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP) · K252757

# CeQur Simplicity™ On-Demand Insulin Delivery System (K252757)

_Cequr SA · OPP · Apr 10, 2026 · General Hospital · SESE_

**Canonical URL:** https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K252757

## Device Facts

- **Applicant:** Cequr SA
- **Product Code:** [OPP](/submissions/HO/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP.md)
- **Decision Date:** Apr 10, 2026
- **Decision:** SESE
- **Submission Type:** Special
- **Regulation:** 21 CFR 880.5725
- **Device Class:** Class 2
- **Review Panel:** General Hospital
- **Attributes:** Therapeutic

## Indications for Use

The CeQur Simplicity™ On-Demand Insulin Delivery System is indicated for the subcutaneous delivery of U-100 rapid-acting insulin for the management of diabetes in adults who require insulin. The device is intended for use by a single patient and is for prescription use only.

## Device Story

CeQur Simplicity™ is a wearable, bolus-only insulin delivery system for adult patients with diabetes. Device delivers rapid-acting U-100 insulin subcutaneously upon user demand. Modification extends wear duration from 4 to 7 days. Device operates as a mechanical infusion pump; no electronic or software-based control. Patient self-administers bolus doses as needed for glycemic control. Healthcare provider prescribes device; patient manages daily insulin dosing. Extended wear duration validated via in vitro insulin-device compatibility testing to ensure insulin efficacy remains stable over 7-day period. Benefit includes reduced frequency of device changes for patients requiring insulin therapy.

## Clinical Evidence

Bench testing only. In vitro insulin-device compatibility study performed to evaluate impact of extended wear duration (up to 7 days) on insulin efficacy. No clinical data required.

## Technological Characteristics

Mechanical infusion pump for subcutaneous insulin delivery. Wearable form factor. Materials and fundamental scientific technology identical to predicate. No electronic components, software, or energy source described. Sterilization method not specified.

## Regulatory Identification

An infusion pump is a device used in a health care facility to pump fluids into a patient in a controlled manner. The device may use a piston pump, a roller pump, or a peristaltic pump and may be powered electrically or mechanically. The device may also operate using a constant force to propel the fluid through a narrow tube which determines the flow rate. The device may include means to detect a fault condition, such as air in, or blockage of, the infusion line and to activate an alarm.

## Predicate Devices

- CeQur Simplicity™ On-Demand Insulin Delivery System ([K252757](/device/K252757.md))

## Submission Summary (Full Text)

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FDA U.S. FOOD & DRUG ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K252757

B Applicant

CeQur SA

C Proprietary and Established Names

CeQur Simplicity™ On-Demand Insulin Delivery System

D Regulatory Information

|  Product Code(s) | Classification | Regulation Section | Panel  |
| --- | --- | --- | --- |
|  OPP | Class II | 880.5725 - Infusion pump | CH – Clinical Chemistry  |
|  LZG | Class II | 880.5725 - Infusion pump | CH – Clinical Chemistry  |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified

Food and Drug Administration

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device has not changed. This change was for extending the intended duration of wear from "up to 4 days" to "up to 7 days."

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied. Verification and validation activities included an insulin-device compatibility study. Given the particular details of this device (e.g., a bolus-only device intended for adult use only), FDA determined that the risks related to loss of insulin efficacy resulting from extended wear duration could be adequately evaluated by in vitro bench testing alone, and therefore in vivo clinical testing was not required.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.

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**Source:** [https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K252757](https://fda.innolitics.com/submissions/CH/subpart-f%E2%80%94general-hospital-and-personal-use-therapeutic-devices/OPP/K252757)

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