Deka Research & Development Corp.
Manchester, NH, US
DEKA RESEARCH & DEVELOPMENT CORP. appears in FDA device records in Manchester, NH. FDA records list 28 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show no recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
FDA records hold 28 510(k) clearances for Deka Research & Development Corp. between 1984 and 2026. The busiest year on record is 2024, with 9. The most recent is 2026, with 2.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1984 | 2 |
| 1986 | 1 |
| 2011 | 2 |
| 2013 | 1 |
| 2015 | 1 |
| 2016 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2020 | 2 |
| 2023 | 1 |
| 2024 | 9 |
| 2025 | 4 |
| 2026 | 2 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K261672 | twiist Automated Insulin Delivery (AID) System | QFG | Substantially Equivalent | |
| K261530 | iiSure Infusion Set | FPA | Substantially Equivalent | |
| K243841 | Sparta Infusion Set for Insulin | FPA | Substantially Equivalent | |
| K250930 | twiist system | QFG | Substantially Equivalent | |
| K250357 | RemunityPRO™ Pump for Remodulin® (treprostinil) Injection | FRN | Substantially Equivalent | |
| K241736 | Remunity 2.0 Pump for Remodulin (treprostinil) Injection | FRN | Substantially Equivalent | |
| K243354 | Remunity System | QJY | Substantially Equivalent | |
| K242693 | DEKA Infusion System, DEKA Administration Set | LDR | Substantially Equivalent | |
| K240920 | HemoCare Bicarbonate Concentrate Set (BCS) | KPO | Substantially Equivalent | |
| K233557 | HemoCare Hemodialysis System | KDI | Substantially Equivalent | |
| K240256 | Remunity System | QJY | Substantially Equivalent | |
| K241178 | DEKA ACE Pump System | QFG | Substantially Equivalent | |
| K234055 | DEKA Loop | QJI | Substantially Equivalent | |
| K233952 | DEKA ACE Pump System | QFG | Substantially Equivalent | |
| K232316 | DEKA Infusion System, DEKA Administration Set | LDR | Substantially Equivalent | |
| K213536 | DEKA ACE Pump System | QFG | Substantially Equivalent | |
| K202690 | Remunity Pump for Remodulin (treprostinil) Injection | QJY | Substantially Equivalent | |
| K191313 | Unity Subcutaneous Infusion System for Remodulin | QJY | Substantially Equivalent | |
| K190182 | Unity Subcutaneous Delivery System for Remodulin | FRN | Substantially Equivalent | |
| K172601 | Next Generation iBOT | IMK | Substantially Equivalent | |
| K153760 | Volumetric Infusion Controller | LDR | Substantially Equivalent | |
| K151525 | Amia Automated PD System with Sharesource | FKX | Substantially Equivalent | |
| K124018 | AMIA AUTOMATED PD SYSTEM | FKX | Substantially Equivalent | |
| K093915 | DEKA TAC DEVICE | FIG | Substantially Equivalent | |
| K103220 | VOYAGER PERITONEAL DIALYSIS SYSTEM | FKX | Substantially Equivalent | |
| K863204 | DEKA JR. | LDR | Substantially Equivalent | |
| K843254 | DK*300 VOLUMETRIC INFUSION CONTROLLER | LDR | Substantially Equivalent | |
| K843054 | DEKA SOLUTION ADMIN. SET DK 302-A | FPA | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1220973 | 1220973 | DEKA RESEARCH & DEVELOPMENT CORP. | 340 Commercial St, Manchester, NH 03101 US | 2026 | and 2 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- QFGAlternate Controller Enabled Insulin Infusion Pump
- NDCCalculator, Drug Dose
- FIGClamp, Tubing, Blood, Automatic
- LDRController, Infusion, Intravascular, Electronic
- KPODialysate Concentrate For Hemodialysis (Liquid Or Powder)
- KDIDialyzer, High Permeability With Or Without Sealed Dialysate System
- QJYInfusion Pump, Drug Specific, Pharmacy-Filled
- PKUInsulin Pump Secondary Display
- QJIInteroperable Automated Glycemic Controller
- FRNPump, Infusion
- FPASet, Administration, Intravascular
- FKXSystem, Peritoneal, Automatic Delivery
- PAEUpper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous Electromyography
- ITIWheelchair, Powered
- IMKWheelchair, Stair Climbing
Recall records
No recall records for this company in the ingested FDA data.
Verification record
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Data as of , FDA export datePage updated Source: openFDA, public domain