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Data / Medical devices / Interoperable Automated Glycemic Controller

Interoperable Automated Glycemic Controller (QJI): 10 FDA-registered makers in 1 country

10 establishments in 1 country are registered with the FDA to make Interoperable Automated Glycemic Controller (product code QJI, Class 2, 21 CFR 862.1356). 9 of them have a 510(k) clearance or PMA approval on file and 0 have a recall event. The FDA has issued 25 510(k) clearances under this code, the latest on October 15, 2026, and lists 0 recall events (0 Class I). FDA data exported November 2, 2026.

SpecStream is the live web data engine for teams and agents. It reads the FDA registration and listing, 510(k), PMA, recall and enforcement files from openFDA every week, and this page is that reading, joined by the FDA's own numbers. Ask for the makers of any device type in any country and new clearances, approvals and recalls arrive in your sheet, CRM, Slack or agent as the FDA publishes them.

Get every maker of this deviceMakers in the United StatesWatch this device
Product code
QJI
Device class
2
Regulation
862.1356
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States10

Makers of Interoperable Automated Glycemic Controller

Registered establishments that manufacture, contract manufacture, remanufacture, reprocess or own the specification of this device, with the 510(k) clearances, PMA approvals and recalls the FDA files under each. Best documented first.

MakerLocationRole510(k) clearancesLatest clearancePMA approvalsRecall eventsClass ISource
Tandem Diabetes Care, Inc.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer5April 24, 2026000api.fda.gov
Medtronic MinimedNorthridge, CA, United StatesManufacturer3February 3, 2026000api.fda.gov
Tandem Diabetes Care, Inc.San Diego, CA, United StatesManufacturer, Repackager or relabeler3November 3, 2023000api.fda.gov
Tandem Diabetes Care, INC.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Specification developer3November 3, 2023000api.fda.gov
Deka Research & Development Corp.Manchester, NH, United StatesSpecification developer2October 15, 2026000api.fda.gov
Insulet CorporationActon, MA, United StatesComplaint file establishment, Manufacturer2December 3, 2025000api.fda.gov
Beta Bionics, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer1May 19, 2023000api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesComplaint file establishment, Manufacturer1March 13, 2024000api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesManufacturer1March 13, 2024000api.fda.gov
Merrimack ManufacturingManchester, NH, United StatesContract manufacturer0000api.fda.gov

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.