FDA.reportPublic FDA data

510(k) K220916

Device
iLet® Dosing Decision Software
Applicant
Beta Bionics, Inc.
510(k) number
K220916
Product code
QJI
Decision
Substantially Equivalent (SESE)
Decision date
2023-05-19
Date received
2022-03-30
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
Vikram Verma
Address
300 Baker Ave., Suite 301 Concord MA US 01742 01742

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

Other 510(k) Records For Product Code QJI#

510(k), Device, Applicant table
510(k)DeviceApplicantDecision date
K260429Control-IQ+ technologyTandem Diabetes Care, Inc.2026-04-24
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
K203689Tidepool LoopTidepool Project2023-01-23