FDA.report

510(k) K260429

Device
Control-IQ+ technology
Applicant
Tandem Diabetes Care, Inc.
510(k) number
K260429
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2026-04-24
Date received
2026-02-10
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
N

Related Records

Applicant Contact

Contact
Amulya Mallavarapu
Address
12400 High Bluff Dr. San Diego CA US 92130 92130

FDA Registration Numbers

Source Documents

510(k) summary PDF

Other 510(k) Records For Product Code QJI

510(k)DeviceApplicantDecision date
K253701SmartGuard Technology; Predictive Low Glucose TechnologyMedtronic Minimed2026-02-03
K253585SmartGuard technology; Predictive Low Glucose technologyMedtronic Minimed, Inc.2026-01-14
K251152DBLG2Diabeloop2025-12-19
K251779Omnipod 5 algorithmInsulet Corporation2025-12-03
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
K234055DEKA LoopDeka Research and Development2024-03-13
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