FDA.reportPublic FDA data

510(k) K234055

Device
DEKA Loop
Applicant
Deka Research and Development
510(k) number
K234055
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2024-03-13
Date received
2023-12-22
Regulation
862.1356
Classification name
Interoperable Automated Glycemic Controller
Medical specialty
Clinical Chemistry
Review panel
Clinical Chemistry
Device class
2
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
No

Applicant Contact#

Contact
Paul Smolenski
Address
340 Commercial St. Manchester NH US 03101 03101

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QJI#

510(k), Device, Applicant table
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K251217SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.2025-08-29
K250798Control-IQ+ technologyTandem Diabetes Care, Inc.2025-05-21
K243823Control-IQ+ technologyTandem Diabetes Care, Inc.2025-02-24
K241777SmartAdjust™ TechnologyInsulet Corporation2024-08-26
K232741SmartAdjust(TM) technologyInsulet Corporation2024-05-29
K232603CamAPS FXCamdiab , Ltd.2024-05-23
K232382Control-IQ TechnologyTandem Diabetes Care, Inc.2023-11-03
K232224iLet® Dosing Decision SoftwareBeta Bionics, Inc.2023-09-22
K220916iLet® Dosing Decision SoftwareBeta Bionics, Inc.2023-05-19
K203689Tidepool LoopTidepool Project2023-01-23