Cequr SA · Class II · Cleared Apr 10, 2026
| K-number | K252757 |
| Device name | CeQur Simplicity On-Demand Insulin Delivery System |
| Applicant | Cequr SA |
| Product code | OPP |
| Device class | Class II |
| Decision date | Apr 10, 2026 |
| Decision | Substantially Equivalent |
| Regulation | 880.5725 |
The CeQur Simplicity™ On-Demand Insulin Delivery System is a sterile, single-use, external insulin delivery device consisting of a disposable insulin patch, fill syringe, and change-by-stickers. It is intended for subcutaneous bolus delivery of insulin to manage diabetes mellitus in adult patients requiring insulin, with the device adhering to skin for up to 7 days.
The technological characteristics of the subject device are identical to the predicate device. Both are manual, user-filled, positive displacement insulin delivery systems with a maximum capacity of 2mL, designed for subcutaneous delivery and worn on the body for up to 7 days.
Not stated in this summary.
View the full FDA submission: accessdata.fda.gov