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Data / Medical devices / United States / Deka Research & Development Corp.

Deka Research & Development Corp.: FDA-registered device maker in Manchester, NH, United States, 20 510(k) clearances

Deka Research & Development Corp. is registered with the FDA (registration 1220973) in Manchester, NH, United States. It lists 12 device types. The FDA files 20 510(k) clearances under its listings, the newest dated October 15, 2026. Registered through 2027. FDA data exported November 2, 2026.

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Get makers like this oneWatch Deka Research & Development Corp.
FDA registration number
1220973
Address
340 Commercial St, Manchester, NH, United States, 03101
Owner or operator
DEKA Research & Development Corp. (10041884)
Roles
Specification developer
First device listed
September 13, 2012
Registered through
2027
Brand names listed
DEKA Arm System, DEKA TAC Device, Volumetric Infusion Controller, iBOT, iBOT Personal Mobility Device (iBOT PMD), twiist AID System, twiist Automated Insulin Delivery (AID) System Powered by Tidepool, twiist Loop and more

Devices it lists

DeviceProduct codeClassRoleSource
Alternate Controller Enabled Insulin Infusion PumpQFG2Specification developeraccessdata.fda.gov
Calculator, Drug DoseNDC2Specification developeraccessdata.fda.gov
Clamp, Tubing, Blood, AutomaticFIG2Specification developeraccessdata.fda.gov
Controller, Infusion, Intravascular, ElectronicLDR2Specification developeraccessdata.fda.gov
Infusion Pump, Drug Specific, Pharmacy-FilledQJY2Specification developeraccessdata.fda.gov
Insulin Pump Secondary DisplayPKU2Specification developeraccessdata.fda.gov
Interoperable Automated Glycemic ControllerQJI2Specification developeraccessdata.fda.gov
Pump, InfusionFRN2Specification developeraccessdata.fda.gov
Set, Administration, IntravascularFPA2Specification developeraccessdata.fda.gov
Upper Extremity Prosthesis With Multiple Simultaneous Degrees Of Freedom And Controlled Via Cutaneous ElectromyographyPAE2Specification developeraccessdata.fda.gov
Wheelchair, PoweredITI2Specification developeraccessdata.fda.gov
Wheelchair, Stair ClimbingIMK2Specification developeraccessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided510(k) numberDeviceProduct codeDecisionApplicantSource
October 15, 2026K262576twiist Loop AlgorithmQJISubstantially EquivalentDeka Research and Development Corp.accessdata.fda.gov
June 17, 2026K261672twiist Automated Insulin Delivery (AID) SystemQFGSubstantially EquivalentDeka Research and Developmentaccessdata.fda.gov
August 1, 2025K243841Sparta Infusion Set for InsulinFPASubstantially EquivalentDeka Research and Developmentaccessdata.fda.gov
April 2, 2025K250930twiist systemQFGSubstantially EquivalentDeka Research & Development Corp.accessdata.fda.gov
March 11, 2025K250357RemunityPRO™ Pump for Remodulin® (treprostinil) InjectionFRNSubstantially EquivalentDeka Research & Development Corp.accessdata.fda.gov
January 30, 2025K243442iBOT® PMDIMKSubstantially EquivalentMobius Mobilityaccessdata.fda.gov
January 16, 2025K241736Remunity 2.0 Pump for Remodulin (treprostinil) InjectionFRNSubstantially EquivalentDeka Research and Development Corp.accessdata.fda.gov
November 27, 2024K243354Remunity SystemQJYSubstantially EquivalentDeka Research & Development Corp.accessdata.fda.gov
October 7, 2024K242693DEKA Infusion System, DEKA Administration SetLDRSubstantially EquivalentDeka Research and Development Corporationaccessdata.fda.gov
May 24, 2024K241178DEKA ACE Pump SystemQFGSubstantially EquivalentDeka Research and Developmentaccessdata.fda.gov
March 13, 2024K234055DEKA LoopQJISubstantially EquivalentDeka Research and Developmentaccessdata.fda.gov
July 25, 2023K213536DEKA ACE Pump SystemQFGSubstantially EquivalentDeka Research and Developmentaccessdata.fda.gov
June 16, 2021K210920iBOT Personal Mobility Device (iBOT PMD)IMKSubstantially EquivalentMobius Mobilityaccessdata.fda.gov
December 30, 2020K202690Remunity Pump for Remodulin (treprostinil) InjectionQJYSubstantially EquivalentDeka Research and Developmentaccessdata.fda.gov
February 21, 2020K191313Unity Subcutaneous Infusion System for RemodulinQJYSubstantially EquivalentDEKA Research & Developmentaccessdata.fda.gov
May 6, 2019K190182Unity Subcutaneous Delivery System for RemodulinFRNSubstantially EquivalentDEKA Research & Developmentaccessdata.fda.gov
March 2, 2018K172601Next Generation iBOTIMKSubstantially EquivalentDeka Research & Development Corp.accessdata.fda.gov
October 3, 2016K153760Volumetric Infusion ControllerLDRSubstantially EquivalentDEKA Research & Developmentaccessdata.fda.gov
May 9, 2014DEN120016DEKA ARM SYSTEMPAEUnknownDeka Integrated Solutions Corporationaccessdata.fda.gov
August 23, 2011K093915DEKA TAC DEVICEFIGSubstantially EquivalentDeka Research & Development Corp.accessdata.fda.gov

Compare with other makers

Updated October 15, 2026. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.