Total clearances
4
2020-02-21 → 2025-04-02
Name variants in FDA filings: Deka Research & Development Corp. / DEKA Research & Development
Trend
Clearance cadence by quarter
Portfolio
Product codes worked
| Code |
Device name |
Class |
Specialty |
Clearances |
Most recent |
| QJY |
Infusion Pump, Drug Specific, Pharmacy-Filled |
Class II |
General Hospital |
2 |
2024-11-27 |
| QFG |
Alternate Controller Enabled Insulin Infusion Pump |
Class II |
Clinical Chemistry |
1 |
2025-04-02 |
| FRN |
Pump, Infusion |
Class II |
General Hospital |
1 |
2025-03-11 |
Filings
All 510(k) clearances (4)
| Date |
K-number |
Device |
Code |
Class |
Specialty |
| 2025-04-02 |
K250930 |
twiist system |
QFG |
Class II |
Clinical Chemistry |
| 2025-03-11 |
K250357 |
RemunityPRO Pump for Remodulin® (treprostinil) Injection |
FRN |
Class II |
General Hospital |
| 2024-11-27 |
K243354 |
Remunity System |
QJY |
Class II |
General Hospital |
| 2020-02-21 |
K191313 |
Unity Subcutaneous Infusion System for Remodulin |
QJY |
Class II |
General Hospital |