Manchester, NH, US · 14 510(k) clearances
| Code | Device name | Class | Specialty | Clearances | Most recent |
|---|---|---|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | Class II | Clinical Chemistry | 4 | 2026-06-17 |
| FPA | Set, Administration, Intravascular | Class II | General Hospital | 2 | 2026-06-03 |
| LDR | Controller, Infusion, Intravascular, Electronic | Class II | General Hospital | 2 | 2024-10-07 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | Class II | General Hospital | 2 | 2024-06-12 |
| FRN | Pump, Infusion | Class II | General Hospital | 1 | 2025-01-16 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | Class II | Gastroenterology, Urology | 1 | 2024-07-12 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | Class II | Gastroenterology, Urology | 1 | 2024-07-12 |
| QJI | Interoperable Automated Glycemic Controller | Class II | Clinical Chemistry | 1 | 2024-03-13 |
| Date | K-number | Device | Code | Class | Specialty |
|---|---|---|---|---|---|
| 2026-06-17 | K261672 | twiist Automated Insulin Delivery (AID) System | QFG | Class II | Clinical Chemistry |
| 2026-06-03 | K261530 | iiSure Infusion Set | FPA | Class II | General Hospital |
| 2025-08-01 | K243841 | Sparta Infusion Set for Insulin | FPA | Class II | General Hospital |
| 2025-01-16 | K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | FRN | Class II | General Hospital |
| 2024-10-07 | K242693 | DEKA Infusion System, DEKA Administration Set | LDR | Class II | General Hospital |
| 2024-07-12 | K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | KPO | Class II | Gastroenterology, Urology |
| 2024-07-12 | K233557 | HemoCare Hemodialysis System | KDI | Class II | Gastroenterology, Urology |
| 2024-06-12 | K240256 | Remunity System | QJY | Class II | General Hospital |
| 2024-05-24 | K241178 | DEKA ACE Pump System | QFG | Class II | Clinical Chemistry |
| 2024-03-13 | K234055 | DEKA Loop | QJI | Class II | Clinical Chemistry |
| 2024-03-13 | K233952 | DEKA ACE Pump System | QFG | Class II | Clinical Chemistry |
| 2024-03-01 | K232316 | DEKA Infusion System, DEKA Administration Set | LDR | Class II | General Hospital |
| 2023-07-25 | K213536 | DEKA ACE Pump System | QFG | Class II | Clinical Chemistry |
| 2020-12-30 | K202690 | Remunity Pump for Remodulin (treprostinil) Injection | QJY | Class II | General Hospital |