Company ยท US
Deka Research and Development
FDA 510(k) clearances and medical device recalls filed under this name, 2015 to 2026. Name variants (Inc, Corp, punctuation) are merged.
16510(k) clearances (3 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 4 |
| FPA | Set, Administration, Intravascular | 2 |
| LDR | Controller, Infusion, Intravascular, Electronic | 2 |
| QJI | Interoperable Automated Glycemic Controller | 2 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | 2 |
| FKX | System, Peritoneal, Automatic Delivery | 1 |
| FRN | Pump, Infusion | 1 |
| KDI | Dialyzer, High Permeability With Or Without Sealed Dialysate System | 1 |
| KPO | Dialysate Concentrate For Hemodialysis (Liquid Or Powder) | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Oct 15, 2026 | K262576 | twiist Loop Algorithm Deka Research and Development Corp. | QJI |
| Jun 17, 2026 | K261672 | twiist Automated Insulin Delivery (AID) System Deka Research and Development | QFG |
| Jun 3, 2026 | K261530 | iiSure Infusion Set Deka Research and Development | FPA |
| Aug 1, 2025 | K243841 | Sparta Infusion Set for Insulin Deka Research and Development | FPA |
| Jan 16, 2025 | K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection Deka Research and Development Corp. | FRN |
| Oct 7, 2024 | K242693 | DEKA Infusion System, DEKA Administration Set Deka Research and Development Corporation | LDR |
| Jul 12, 2024 | K240920 | HemoCare Bicarbonate Concentrate Set (BCS) Deka Research and Development | KPO |
| Jul 12, 2024 | K233557 | HemoCare Hemodialysis System Deka Research and Development | KDI |
| Jun 12, 2024 | K240256 | Remunity System Deka Research and Development | QJY |
| May 24, 2024 | K241178 | DEKA ACE Pump System Deka Research and Development | QFG |
| Mar 13, 2024 | K234055 | DEKA Loop Deka Research and Development | QJI |
| Mar 13, 2024 | K233952 | DEKA ACE Pump System Deka Research and Development | QFG |
| Mar 1, 2024 | K232316 | DEKA Infusion System, DEKA Administration Set Deka Research and Development | LDR |
| Jul 25, 2023 | K213536 | DEKA ACE Pump System Deka Research and Development | QFG |
| Dec 30, 2020 | K202690 | Remunity Pump for Remodulin (treprostinil) Injection Deka Research and Development | QJY |
| Oct 9, 2015 | K151525 | Amia Automated PD System with Sharesource Deka Research and Development | FKX |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||