| 2026-06-17 |
K261672 |
twiist Automated Insulin Delivery (AID) System |
QFG |
Class II |
Clinical Chemistry |
| 2026-06-03 |
K261530 |
iiSure Infusion Set |
FPA |
— |
— |
| 2025-08-01 |
K243841 |
Sparta Infusion Set for Insulin |
FPA |
— |
— |
| 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 |
— |
— |
| 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 |
— |
— |
| 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 |