Company · US
Deka Research & Development Corp.
FDA 510(k) clearances and medical device recalls filed under this name, 1984 to 2025. Name variants (Inc, Corp, punctuation) are merged.
13510(k) clearances (0 in 12 months)
0recalls (0 in 12 months)
0recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| LDR | Controller, Infusion, Intravascular, Electronic | 3 |
| FKX | System, Peritoneal, Automatic Delivery | 2 |
| FRN | Pump, Infusion | 2 |
| QJY | Infusion Pump, Drug Specific, Pharmacy-Filled | 2 |
| FIG | Clamp, Tubing, Blood, Automatic | 1 |
| FPA | Set, Administration, Intravascular | 1 |
| IMK | Wheelchair, Stair Climbing | 1 |
| QFG | Alternate Controller Enabled Insulin Infusion Pump | 1 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Apr 2, 2025 | K250930 | twiist system Deka Research & Development Corp. | QFG |
| Mar 11, 2025 | K250357 | RemunityPRO Pump for Remodulin® (treprostinil) Injection Deka Research & Development Corp. | FRN |
| Nov 27, 2024 | K243354 | Remunity System Deka Research & Development Corp. | QJY |
| Feb 21, 2020 | K191313 | Unity Subcutaneous Infusion System for Remodulin DEKA Research & Development | QJY |
| May 6, 2019 | K190182 | Unity Subcutaneous Delivery System for Remodulin DEKA Research & Development | FRN |
| Mar 2, 2018 | K172601 | Next Generation iBOT Deka Research & Development Corp. | IMK |
| Oct 3, 2016 | K153760 | Volumetric Infusion Controller DEKA Research & Development | LDR |
| Jun 14, 2013 | K124018 | AMIA AUTOMATED PD SYSTEM Deka Research & Development Corp. | FKX |
| Aug 23, 2011 | K093915 | DEKA TAC DEVICE Deka Research & Development Corp. | FIG |
| Jul 29, 2011 | K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM Deka Research & Development Corp. | FKX |
| Sep 3, 1986 | K863204 | DEKA JR. Deka Research & Development Corp. | LDR |
| Oct 11, 1984 | K843254 | DK*300 VOLUMETRIC INFUSION CONTROLLER Deka Research & Development Corp. | LDR |
| Sep 13, 1984 | K843054 | DEKA SOLUTION ADMIN. SET DK 302-A Deka Research & Development Corp. | FPA |
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| No recalls in this window. | |||