510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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QJIClass II

Interoperable Automated Glycemic Controller

21 CFR 862.1356 / Clinical Chemistry
FDA source (opens on fda.gov)

QJI is the FDA product code for Interoperable Automated Glycemic Controller, a class II device type, regulated under 21 CFR 862.1356. FDA's definition for this code reads: "An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed...". As of , FDA records hold 22 510(k) clearances under this code, the most recent dated , and no recalls.

Classification record

Product code
QJI
Device name
Interoperable Automated Glycemic Controller
FDA definition
An interoperable automated glycemic controller is a device intended to automatically calculate drug doses based on inputs such as glucose and other relevant physiological parameters, and to command the delivery of such drug doses from a connected infusion pump. Interoperable automated glycemic controllers are designed to reliably and securely communicate with digitally connected devices to allow drug delivery commands to be sent, received, executed, and confirmed. Interoperable automated glycemic controllers are intended to be used in conjunction with digitally connected devices for the purpose of maintaining glycemic control.
Regulation
21 CFR 862.1356
Device class
Class II
Review panel
Clinical Chemistry
Submission type
510(k)
Implant
No
Life sustaining or supporting
No
GMP exempt
No
Third party review eligible
No
Ingested clearances
24
Ingested recalls
0

Clearances, product code QJI

By decision year
24 clearances under product code QJI with a decision year between 2019 and 2026, 2026 the highest year at 7.
Show the numbers
510(k) clearances under FDA product code QJI by decision year
YearClearances
20191
20201
20222
20234
20244
20255
20267

Applicants with the most clearances

Product code QJI
Applicants holding the most 510(k) clearances under product code QJI
ApplicantClearances
Insulet Corporation6
Tandem Diabetes Care, Inc.6
Medtronic, Inc.4
Beta Bionics, Inc.2
Beta Bionics, Inc.1
CamDiab1
Camdiab, Ltd.1
Deka Research & Development Corp.1
Diabeloop1
Tidepool Project1

Companies listing this code with FDA

Companies whose registered establishments list this code