Deka Research and Development
FDA Regulatory Profile
Summary
- Total Recalls
- 0
- 510(k) Clearances
- 25
- Inspections
- 5
- Compliance Actions
- 0
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243841 | Sparta Infusion Set for Insulin | August 1, 2025 |
| K250930 | twiist system | April 2, 2025 |
| K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection | March 11, 2025 |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | January 16, 2025 |
| K243354 | Remunity System | November 27, 2024 |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | July 12, 2024 |
| K233557 | HemoCare Hemodialysis System | July 12, 2024 |
| K240256 | Remunity System | June 12, 2024 |
| K241178 | DEKA ACE Pump System | May 24, 2024 |
| K233952 | DEKA ACE Pump System | March 13, 2024 |
| K234055 | DEKA Loop | March 13, 2024 |
| K232316 | DEKA Infusion System, DEKA Administration Set | March 1, 2024 |
| K213536 | DEKA ACE Pump System | July 25, 2023 |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | December 30, 2020 |
| K191313 | Unity Subcutaneous Infusion System for Remodulin | February 21, 2020 |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | May 6, 2019 |
| K172601 | Next Generation iBOT | March 2, 2018 |
| K153760 | Volumetric Infusion Controller | October 3, 2016 |
| K151525 | Amia Automated PD System with Sharesource | October 9, 2015 |
| K124018 | AMIA AUTOMATED PD SYSTEM | June 14, 2013 |