Data / Medical devices / United States / Radiometer Minneapolis

Radiometer Minneapolis: FDA-registered device maker in New Brighton, MN, United States, 2 510(k) clearances

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

Radiometer Minneapolis is registered with the FDA (registration 3014506106) in New Brighton, MN, United States. It lists 10 device types. The FDA files 2 510(k) clearances under its listings, the newest dated December 7, 2015. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3014506106
Address: 121 5th Avenue W, New Brighton, MN, United States, 55112
Owner or operator: RADIOMETER MEDICAL APS (8020503)
Roles: Manufacturer, Manufacturer for export
First device listed: June 28, 2022
Registered through: 2026
Brand names listed: ABL80 CO-OX, ABL80 FLEX, ABL80 FLEX CO-OX with AQURE, ABL9

Devices it lists

Device	Product code	Class	Role	Source
Assay, Carboxyhemoglobin	GHS	2	Manufacturer	accessdata.fda.gov
Device, Hematocrit Measuring	JPI	2	Manufacturer	accessdata.fda.gov
Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph	CHL	2	Manufacturer, Manufacturer for export	accessdata.fda.gov
Electrode, Ion Specific, Calcium	JFP	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Potassium	CEM	2	Manufacturer	accessdata.fda.gov
Electrode, Ion Specific, Sodium	JGS	2	Manufacturer	accessdata.fda.gov
Electrode, Ion-Specific, Chloride	CGZ	2	Manufacturer	accessdata.fda.gov
Glucose Oxidase, Glucose	CGA	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
System, Hemoglobin, Automated	GKR	2	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
December 7, 2015	K151639	ABL80 FLEX and ABL80 FLEX CO-OX	CGA	Substantially Equivalent	Sendx Medical, Inc.	accessdata.fda.gov
August 6, 2015	K151856	ABL80 FLEX CO-OX with AQURE connectivity	CHL	Substantially Equivalent	Sendx Medical, Inc.	accessdata.fda.gov

Compare with other makers

Updated December 7, 2015. 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.