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Intricon Corporation: FDA-registered device maker in Arden Hills, MN, United States, 1 510(k) clearance and 1 PMA approval

Name: Intricon Corporation FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Intricon Corporation is registered with the FDA (registration 2134850) in Arden Hills, MN, United States. It lists 7 device types. The FDA files 1 510(k) clearance and 1 PMA approval under its listings, the newest dated May 19, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2134850
FEI number: 3003007876
Address: 1260 Red Fox Rd, Arden Hills, MN, United States, 55112
Owner or operator: INTRICON CORPORATION (9039676)
Roles: Contract manufacturer, Manufacturer
First device listed: January 11, 2013
Registered through: 2026
Brand names listed: Electromagnetic Tracker, Endobronchial Biopsy Brush, Endobronchial Guidewire, Flexible Biopsy Needle, Percutaneous Biopsy Needle, Percutaneous Localization Needle

Devices it lists

Device	Product code	Class	Role	Source
Automated Insulin Dosing , Threshold Suspend	OZO	3	Contract manufacturer	accessdata.fda.gov
Automated Insulin Dosing Device System, Single Hormonal Control	OZP	3	Contract manufacturer	accessdata.fda.gov
Continuous Glucose Monitor Secondary Display	PJT	2	Manufacturer	accessdata.fda.gov
Insulin Pump Secondary Display	PKU	2	Manufacturer	accessdata.fda.gov
Pump, Infusion, Insulin, To Be Used With Invasive Glucose Sensor	OYC	3	Manufacturer	accessdata.fda.gov
Sensor, Glucose, Invasive	MDS	3	Contract manufacturer, Manufacturer	accessdata.fda.gov
System, X-Ray, Tomography, Computed	JAK	2	Contract manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 19, 2015	K151236	MiniMed Connect kit, MiniMed Connect uploader, MiniMed Connect app, CareLink Connect (CareLink Personal)	PJT	Substantially Equivalent	Medtronic Minimed, Inc.	accessdata.fda.gov

PMA approvals

Premarket approvals this establishment lists, with the supplements the FDA has decided since.

Approved	PMA number	Device	Product code	Supplements	Latest decision	Source
June 15, 1999	P980022	CONTINUOUS GLUCOSE MONITORING SYSTEM	MDS	186	August 14, 2019	accessdata.fda.gov

Compare with other makers

Updated August 14, 2019. 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.