Deka Research and Development
FDA 510(k) & PMA Approved Devices — 12 products
Total Devices12
Categories7
Latest FDA decision2026-06-17
| Type | Number | Device Name | Code | Date | Actions |
|---|---|---|---|---|---|
| 510(k) | K261672 | twiist Automated Insulin Delivery (AID) System | QFG | 2026-06-17 | View |
| 510(k) | K261530 | iiSure Infusion Set | FPA | 2026-06-03 | View |
| 510(k) | K243841 | Sparta Infusion Set for Insulin | FPA | 2025-08-01 | View |
| 510(k) | K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | KPO | 2024-07-12 | View |
| 510(k) | K233557 | HemoCare Hemodialysis System | KDI | 2024-07-12 | View |
| 510(k) | K240256 | Remunity System | QJY | 2024-06-12 | View |
| 510(k) | K241178 | DEKA ACE Pump System | QFG | 2024-05-24 | View |
| 510(k) | K234055 | DEKA Loop | QJI | 2024-03-13 | View |
| 510(k) | K233952 | DEKA ACE Pump System | QFG | 2024-03-13 | View |
| 510(k) | K232316 | DEKA Infusion System, DEKA Administration Set | LDR | 2024-03-01 | View |
| 510(k) | K213536 | DEKA ACE Pump System | QFG | 2023-07-25 | View |
| 510(k) | K202690 | Remunity Pump for Remodulin (treprostinil) Injection | QJY | 2020-12-30 | View |
No matching devices.