Data / Medical devices / Automated Insulin Dosing , Threshold Suspend / United States
FDA-registered makers of Automated Insulin Dosing , Threshold Suspend in the United States: 10 establishments
10 establishments in the United States are registered with the FDA to make Automated Insulin Dosing , Threshold Suspend (product code OZO). 6 have a 510(k) clearance or PMA approval on file and 1 has a recall event. FDA data exported November 2, 2026.
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- Device
- Automated Insulin Dosing , Threshold Suspend
- Product code
- OZO
- Country
- United States
Makers of Automated Insulin Dosing , Threshold Suspend in the United States
| 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, Manufacturer for export | 0 | 2 | 9 | 2 | api.fda.gov | |
| Medtronic Puerto Rico Operations Co., Juncos | Juncos, PR, United States | Manufacturer, Manufacturer for export, Remanufacturer | 0 | 2 | 0 | 0 | api.fda.gov | |
| Ascensia Diabetes Care US Inc. | Parsippany, NJ, United States | Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Ascensia Diabetes Care US Inc. | Valhalla, NY, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, Inc. | San Diego, CA, United States | Manufacturer, Remanufacturer, Repackager or relabeler | 0 | 1 | 0 | 0 | api.fda.gov | |
| Tandem Diabetes Care, INC. | San Diego, CA, United States | Complaint file establishment, Specification developer | 0 | 1 | 0 | 0 | api.fda.gov | |
| Intricon Corporation | Arden Hills, MN, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov | |
| IntriCon Corporation Grey Fox | Arden Hills, MN, United States | 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 | |
| RR Donnelley-Supply Chain Solutions | Plover, WI, United States | Contract manufacturer | 0 | 0 | 0 | 0 | api.fda.gov |
Updated November 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.