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.
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.
- Product code
- LZG
- Device class
- 2
- Regulation
- 880.5725
- Medical specialty
- General Hospital
Makers by country
| Country | Makers |
|---|---|
| United States | 9 |
| China | 4 |
| Mexico | 3 |
| Switzerland | 2 |
| South Korea | 1 |
| Germany | 1 |
| Poland | 1 |
| Costa Rica | 1 |
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.
| Maker | Location | Role | 510(k) clearances | Latest clearance | PMA approvals | Recall events | Class I | Source |
|---|---|---|---|---|---|---|---|---|
| Medtronic Minimed | Northridge, CA, United States | Complaint file establishment, Manufacturer, Specification developer | 6 | April 6, 2022 | 0 | 12 | 1 | api.fda.gov |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Complaint file establishment, Specification developer | 6 | October 25, 2016 | 0 | 1 | 1 | api.fda.gov |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 6 | October 25, 2016 | 0 | 0 | 0 | api.fda.gov |
| Sooil Development Co., Ltd. | Yongin-si Gyeonggi, South Korea | Exporter to the US, Manufacturer | 3 | February 2, 2007 | 0 | 0 | 0 | api.fda.gov |
| Insulet Corporation | Acton, MA, United States | Complaint file establishment, Manufacturer, Manufacturer for export | 2 | April 24, 2023 | 0 | 5 | 2 | api.fda.gov |
| Mannkind Corporation | Danbury, CT, United States | Complaint file establishment, Specification developer | 2 | February 23, 2011 | 0 | 0 | 0 | api.fda.gov |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer | 2 | April 6, 2022 | 0 | 0 | 0 | api.fda.gov |
| Roche Diagnostics GMBH | MANNHEIM Baden-Wurttemberg, Germany | Specification developer | 2 | June 15, 2006 | 0 | 0 | 0 | api.fda.gov |
| ICU Medical Healthcare Manufacturing S.A. de C.V. | Tijuana, B.C. C.P. Baja California, Mexico | Manufacturer | 1 | May 27, 2004 | 0 | 0 | 0 | api.fda.gov |
| Modular Medical | San Diego, CA, United States | Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer | 1 | April 8, 2026 | 0 | 0 | 0 | api.fda.gov |
| Advance Technology Ltd | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| AvailMed S.A.De C.V. | Tijuana Baja California, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| CeQur SA | Horw Luzern, Switzerland | Specification developer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Clinico Medical Sp. z o.o. | Blonie/Miekinia Dolnoslaskie, Poland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Flextronics Industrial (Shenzhen) Co., Ltd. | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IntriCon Corporation VH | Vadnais Heights, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Omni Manufacturing Services S. A. De C. V. | Queretaro, Mexico | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Providence Enterprise Limited | Shenzhen Guangdong, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Roche Diabetes Care, Inc. | Indianapolis, IN, United States | Manufacturer | 0 | 0 | 2 | 0 | api.fda.gov | |
| Sanmina | Kunshan Jiangsu, China | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Ypsomed AG | BURGDORF Bern, Switzerland | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| Zollner Electronics Costa Rica Limitada | Cartago, Costa Rica | Contract manufacturer | 0 | 0 | 0 | 0 | api.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.