Deka Research and Development - FDA 510(k) Cleared Devices
Recent clearances: iiSure Infusion Set, Sparta Infusion Set for Insulin, HemoCare Hemodialysis System
13
Total
13
Cleared
0
Denied
FDA 510(k) Regulatory Record - Deka Research and Development Chemistry ✕
7 devices
Cleared
Jun 17, 2026
twiist Automated Insulin Delivery (AID) System
Chemistry
27d
Cleared
Jun 03, 2026
iiSure Infusion Set
Chemistry
26d
Cleared
Aug 01, 2025
Sparta Infusion Set for Insulin
Chemistry
231d
Cleared
May 24, 2024
DEKA ACE Pump System
Chemistry
25d
Cleared
Mar 13, 2024
DEKA ACE Pump System
Chemistry
89d
Cleared
Mar 13, 2024
DEKA Loop
Chemistry
82d
Cleared
Jul 25, 2023
DEKA ACE Pump System
Chemistry
627d