CeQur Simplicity On-Demand Insulin Delivery System— 510(k) K252757
Substantially EquivalentCequr SA
FDA 510(k) clearance K252757 for CeQur Simplicity On-Demand Insulin Delivery System, Substantially Equivalent on 2026-04-10. Applicant: Cequr SA. Device class: 2.
Summary
The CeQur Simplicity is a wearable insulin patch that delivers mealtime bolus doses on demand, with no basal infusion. Product code OPP covers bolus-only insulin infusion pumps, which fits.
Class II, 21 CFR 880.5725, General Hospital panel. CeQur filed it as a Special 510(k), meaning a modification to a device it already had cleared.
Cequr SA filed from Horw, near Lucerne, Switzerland. The review took 224 days (August 29, 2025 to April 10, 2026). That's long for a Special, a pathway meant for contained changes, and suggests FDA asked for more than the first submission provided.
Clearance details
- Applicant
- Cequr SA
- Product code
- Code OPP
- Device class
- Class 2
- Regulation
- 21 CFR 880.5725
- Advisory panel
- General Hospital
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Location
- Horw Luzern, CH
Recent devices under product code OPP
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