K252757
- 510(k) number
- K252757
- Device name
- CeQur Simplicity On-Demand Insulin Delivery System
- Applicant
- Cequr SA CH
- Product code
- OPP — Pump, Infusion, Insulin Bolus
- Decision date
- 2026-04-10
- Date received
- 2025-08-29
- Decision
- Substantially Equivalent
- Clearance type
- Special
- Advisory committee
- General Hospital
PDFDownload 510(k) SummaryArchived here · 0.7 MB · U.S. public domain
Also available from FDA: K252757.pdf
Official FDA record: K252757
Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.