Data / Medical devices / Automated Insulin Dosing , Threshold Suspend

Automated Insulin Dosing , Threshold Suspend (OZO): 15 FDA-registered makers in 5 countries

Name: FDA-registered makers of Automated Insulin Dosing , Threshold Suspend
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

15 establishments in 5 countries are registered with the FDA to make Automated Insulin Dosing , Threshold Suspend (product code OZO, Class 3). 8 of them have a 510(k) clearance or PMA approval on file and 1 has a recall event. The FDA has issued 0 510(k) clearances under this code, and lists 9 recall events (2 Class I). FDA data exported November 2, 2026.

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Product code: OZO
Device class: 3
Medical specialty: Unknown

Makers by country

Country	Makers
United States	10
Japan	2
Switzerland	1
Poland	1
Mexico	1

Makers of Automated Insulin Dosing , Threshold Suspend

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	PMA approvals	Recall events	Class I	Source
Medtronic Minimed	Northridge, CA, United States	Complaint file establishment, Manufacturer, Manufacturer for export	2	9	2	api.fda.gov
Medtronic Puerto Rico Operations Co., Juncos	Juncos, PR, United States	Manufacturer, Manufacturer for export, Remanufacturer	2	0	0	api.fda.gov
Ascensia Diabetes Care Holdings AG	Basel Basel-Stadt, Switzerland	Specification developer	1	0	0	api.fda.gov
Ascensia Diabetes Care Poland Sp. z o.o.	Warszawa Mazowieckie, Poland	Specification developer	1	0	0	api.fda.gov
Ascensia Diabetes Care US Inc.	Parsippany, NJ, United States	Specification developer	1	0	0	api.fda.gov
Ascensia Diabetes Care US Inc.	Valhalla, NY, United States	Complaint file establishment, Specification developer	1	0	0	api.fda.gov
Tandem Diabetes Care, Inc.	San Diego, CA, United States	Manufacturer, Remanufacturer, Repackager or relabeler	1	0	0	api.fda.gov
Tandem Diabetes Care, INC.	San Diego, CA, United States	Complaint file establishment, Specification developer	1	0	0	api.fda.gov
AvailMed S.A.De C.V.	Tijuana Baja California, Mexico	Contract manufacturer	0	0	0	api.fda.gov
Intricon Corporation	Arden Hills, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
IntriCon Corporation Grey Fox	Arden Hills, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
IntriCon Corporation VH	Vadnais Heights, MN, United States	Contract manufacturer	0	0	0	api.fda.gov
PHC Corporation	TOON Ehime, Japan	Contract manufacturer	0	0	0	api.fda.gov
PHC Corporation	MIMA Tokushima, Japan	Contract manufacturer	0	0	0	api.fda.gov
RR Donnelley-Supply Chain Solutions	Plover, WI, United States	Contract manufacturer	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.