Medical Device Manufacturer · US , Manchester , NH

Deka Research and Development

11 submissions · 11 cleared · Since 2015
11
Total
11
Cleared
0
Denied

Deka Research and Development — FDA 510(k) Submissions

Deka Research and Development has submitted 11 FDA 510(k) premarket notifications since 2015, of which 11 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Alternate Controller Enabled Insulin Infusion Pump, Infusion Pump, Drug Specific, Pharmacy-filled, Controller, Infusion, Intravascular, Electronic, Dialyzer, High Permeability With Or Without Sealed Dialysate System, Interoperable Automated Glycemic Controller . Use the specialty filter in the sidebar to narrow results.

11 devices
1–11 of 11
Sparta Infusion Set for Insulin
K243841 · FPA Set, Administration,... · Chemistry
Aug 2025 231d
HemoCare Hemodialysis System
K233557 · KDI Dialyzer, High... · Gastroenterology & Urology
Jul 2024 249d
HemoCare Bicarbonate Concentrate Set (BCS)
K240920 · KPO Dialysate Concentrate For... · Gastroenterology & Urology
Jul 2024 99d
Remunity System
K240256 · QJY Infusion Pump, Drug... · General Hospital
Jun 2024 133d
DEKA ACE Pump System
K241178 · QFG Alternate Controller... · Chemistry
May 2024 25d
DEKA ACE Pump System
K233952 · QFG Alternate Controller... · Chemistry
Mar 2024 89d
DEKA Loop
K234055 · QJI Interoperable Automated... · Chemistry
Mar 2024 82d
DEKA Infusion System, DEKA Administration Set
K232316 · LDR Controller, Infusion,... · General Hospital
Mar 2024 211d
DEKA ACE Pump System
K213536 · QFG Alternate Controller... · Chemistry
Jul 2023 627d
Remunity Pump for Remodulin (treprostinil) Injection
K202690 · QJY Infusion Pump, Drug... · General Hospital
Dec 2020 106d
Amia Automated PD System with Sharesource
K151525 · FKX System, Peritoneal,... · Gastroenterology & Urology
Oct 2015 123d
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