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Data / Medical devices / Alternate Controller Enabled Insulin Infusion Pump

Alternate Controller Enabled Insulin Infusion Pump (QFG): 17 FDA-registered makers in 4 countries

17 establishments in 4 countries are registered with the FDA to make Alternate Controller Enabled Insulin Infusion Pump (product code QFG, Class 2, 21 CFR 880.5730). 11 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 30 510(k) clearances under this code, the latest on October 21, 2026, and lists 22 recall events (7 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
QFG
Device class
2
Regulation
880.5730
Medical specialty
Clinical Chemistry

Makers by country

CountryMakers
United States13
Mexico2
Malaysia1
China1

Makers of Alternate Controller Enabled Insulin Infusion Pump

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, Remanufacturer, Repackager or relabeler, Specification developer9November 6, 2025094api.fda.gov
Tandem Diabetes Care, Inc.San Diego, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler7July 26, 2024000api.fda.gov
Tandem Diabetes Care, INC.San Diego, CA, United StatesComplaint file establishment, Manufacturer, Remanufacturer, Repackager or relabeler, Specification developer7July 26, 2024000api.fda.gov
Tandem Diabetes Care, Inc.San Diego, CA, United StatesManufacturer6July 26, 2024000api.fda.gov
Deka Research & Development Corp.Manchester, NH, United StatesSpecification developer4June 17, 2026000api.fda.gov
Medtronic MinimedNorthridge, CA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export3March 12, 2026050api.fda.gov
Beta Bionics, Inc.Irvine, CA, United StatesComplaint file establishment, Manufacturer2October 21, 2026030api.fda.gov
Insulet CorporationActon, MA, United StatesComplaint file establishment, Manufacturer, Specification developer2October 18, 2023053api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesComplaint file establishment, Manufacturer2April 2, 2025000api.fda.gov
Medtronic Puerto Rico Operations Co., JuncosJuncos, PR, United StatesManufacturer1July 1, 2025000api.fda.gov
Millyard Advanced Medical Products LLCManchester, NH, United StatesManufacturer1April 2, 2025000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
Insulet Malaysia Sdn. Bhd.Iskandar Puteri Johor, MalaysiaContract manufacturer0000api.fda.gov
Merrimack ManufacturingManchester, NH, United StatesContract manufacturer0000api.fda.gov
Merrimack ManufacturingManchester, NH, United StatesContract manufacturer0000api.fda.gov
NPA de Mexico S.de R.L. de C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
SanminaKunshan Jiangsu, ChinaContract manufacturer0000api.fda.gov

Updated October 21, 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.