Data / Medical devices / United States / Medical Graphics Corp.

Medical Graphics Corp.: FDA-registered device maker in Saint Paul, MN, United States, 9 510(k) clearances

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

Medical Graphics Corp. is registered with the FDA (registration 2183022) in Saint Paul, MN, United States. It lists 8 device types. The FDA files 9 510(k) clearances under its listings, the newest dated November 26, 2025. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 2183022
Address: 350 Oak Grove Pkwy, Saint Paul, MN, United States, 55127
Owner or operator: MEDICAL GRAPHICS CORP. (2183022)
Roles: Manufacturer, Specification developer
First device listed: October 30, 2007
Registered through: 2026
Brand names listed: 1085D, 1085DL, 1085DX, Ascent Cardiorespiratory Diagnostic Software, Athlete 870C, CCM, CCM Max, CPF-S/D and more

Devices it lists

Device	Product code	Class	Role	Source
Calculator, Predicted Values, Pulmonary Function	BTY	2	Manufacturer	accessdata.fda.gov
Calculator, Pulmonary Function Data	BZC	2	Manufacturer	accessdata.fda.gov
Calculator, Pulmonary Function Interpretor (Diagnostic)	BZM	2	Manufacturer	accessdata.fda.gov
Computer, Oxygen-Uptake	BZL	2	Manufacturer	accessdata.fda.gov
Plethysmograph, Pressure	CCM	2	Manufacturer	accessdata.fda.gov
Pneumotachometer	JAX	2	Manufacturer	accessdata.fda.gov
System, Test, Breath Nitric Oxide	MXA	2	Manufacturer	accessdata.fda.gov
Treadmill, Powered	IOL	1	Specification developer	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
November 26, 2025	K251674	Fenom Flo FeNO Monitoring System	MXA	Substantially Equivalent	Mgc Diagnostics Corporation	accessdata.fda.gov
October 17, 2024	K242809	Ascent Cardiorespiratory Diagnostic Software	BTY	Substantially Equivalent	Medical Graphics Corporation	accessdata.fda.gov
June 7, 2023	K213611	Fenom Pro	MXA	Substantially Equivalent	Caire Diagnostics, Inc.	accessdata.fda.gov
April 12, 2019	K181912	Ascent Cardiorespiratory Diagnostic Software	BTY	Substantially Equivalent	Medical Graphics Corporation	accessdata.fda.gov
April 16, 2007	K070858	EXPRESS SERIES	BZL	Substantially Equivalent	Medical Graphics Corp.	accessdata.fda.gov
September 6, 2006	K061731	MEDGRAPHICS ULTIMA SYSTEM	BZL	Substantially Equivalent	Medical Graphics Corp.	accessdata.fda.gov
April 10, 1995	K943259	1085 ULTIMATE E PLETHYSMOGRAPH	CCM	Substantially Equivalent	Medical Graphics Corp.	accessdata.fda.gov
January 20, 1990	K896345	EXERCISE EVALUATION SYSTEM 2010	BZM	Substantially Equivalent	Medical Graphics Corp.	accessdata.fda.gov
September 25, 1987	K871711	MEDICAL GRAPHICS DESKTOP DIAGNOSTIC SYSTEM	BZM	Substantially Equivalent	Medical Graphics Corp.	accessdata.fda.gov

Compare with other makers

Updated November 26, 2025. 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.