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Data / Medical devices / Pump, Infusion, Insulin

Pump, Infusion, Insulin (LZG): 22 FDA-registered makers in 8 countries

22 establishments in 8 countries are registered with the FDA to make Pump, Infusion, Insulin (product code LZG, Class 2, 21 CFR 880.5725). 10 of them have a 510(k) clearance or PMA approval on file and 4 have a recall event. The FDA has issued 85 510(k) clearances under this code, the latest on September 2, 2026, and lists 58 recall events (7 Class I). FDA data exported November 2, 2026.

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Product code
LZG
Device class
2
Regulation
880.5725
Medical specialty
General Hospital

Makers by country

CountryMakers
United States9
China4
Mexico3
Switzerland2
South Korea1
Germany1
Poland1
Costa Rica1

Makers of Pump, Infusion, Insulin

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
Medtronic MinimedNorthridge, CA, United StatesComplaint file establishment, Manufacturer, Specification developer6April 6, 20220121api.fda.gov
Tandem Diabetes Care, Inc.San Diego, CA, United StatesComplaint file establishment, Specification developer6October 25, 2016011api.fda.gov
Tandem Diabetes Care, INC.San Diego, CA, United StatesManufacturer, Remanufacturer, Repackager or relabeler6October 25, 2016000api.fda.gov
Sooil Development Co., Ltd.Yongin-si Gyeonggi, South KoreaExporter to the US, Manufacturer3February 2, 2007000api.fda.gov
Insulet CorporationActon, MA, United StatesComplaint file establishment, Manufacturer, Manufacturer for export2April 24, 2023052api.fda.gov
Mannkind CorporationDanbury, CT, United StatesComplaint file establishment, Specification developer2February 23, 2011000api.fda.gov
Medtronic Puerto Rico Operations Co., JuncosJuncos, PR, United StatesManufacturer2April 6, 2022000api.fda.gov
Roche Diagnostics GMBHMANNHEIM Baden-Wurttemberg, GermanySpecification developer2June 15, 2006000api.fda.gov
ICU Medical Healthcare Manufacturing S.A. de C.V.Tijuana, B.C. C.P. Baja California, MexicoManufacturer1May 27, 2004000api.fda.gov
Modular MedicalSan Diego, CA, United StatesComplaint file establishment, Manufacturer, Repackager or relabeler, Specification developer1April 8, 2026000api.fda.gov
Advance Technology LtdShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
AvailMed S.A.De C.V.Tijuana Baja California, MexicoContract manufacturer0000api.fda.gov
CeQur SAHorw Luzern, SwitzerlandSpecification developer0000api.fda.gov
Clinico Medical Sp. z o.o.Blonie/Miekinia Dolnoslaskie, PolandContract manufacturer0000api.fda.gov
Flextronics Industrial (Shenzhen) Co., Ltd.Shenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
IntriCon Corporation VHVadnais Heights, MN, United StatesContract manufacturer0000api.fda.gov
Omni Manufacturing Services S. A. De C. V.Queretaro, MexicoContract manufacturer0000api.fda.gov
Providence Enterprise LimitedShenzhen Guangdong, ChinaContract manufacturer0000api.fda.gov
Roche Diabetes Care, Inc.Indianapolis, IN, United StatesManufacturer0020api.fda.gov
SanminaKunshan Jiangsu, ChinaContract manufacturer0000api.fda.gov
Ypsomed AGBURGDORF Bern, SwitzerlandContract manufacturer0000api.fda.gov
Zollner Electronics Costa Rica LimitadaCartago, Costa RicaContract manufacturer0000api.fda.gov

Updated September 2, 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.