Panels › General Hospital › Product code OPP · Class 2
Pump, Infusion, Insulin Bolus
Regulation 880.5725
1510(k)s in 12 months (7 all time)
0recalls in 12 months (1 all time)
1recalls that name a 510(k)
Top companies in OPP
| Company | 510(k)s | Recalls |
|---|---|---|
| Calibra Medical, Inc. | 3 | 0 |
| Cequr SA | 3 | 0 |
| Lifescan Europe, A Division of Cilag GmbH | 1 | 0 |
| Zyno Medical LLC | 0 | 1 |
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 10, 2026 | K252757 | CeQur Simplicity On-Demand Insulin Delivery System Cequr SA, CH | OPP |
| Nov 13, 2024 | K243273 | CeQur Simplicity On-Demand Insulin Delivery System Cequr SA, CH | OPP |
| Jan 18, 2024 | K233447 | CeQur Simplicity On-Demand Insulin Delivery System Cequr SA, CH | OPP |
| Jun 7, 2017 | K163357 | OneTouch Via On-Demand Insulin Delivery System Lifescan Europe, A Division of Cilag GmbH, CH | OPP |
| Apr 10, 2012 | K111924 | FINESSE PERSONAL INSULIN DELIVERY PATCH Calibra Medical, Inc. | OPP |
| Jun 28, 2010 | K100947 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG 2000 Calibra Medical, Inc. | OPP |
| Jan 20, 2010 | K093065 | FINESSE PERSONAL INSULIN DELIVERY PATCH, MODEL FG-2000 Calibra Medical, Inc. | OPP |
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