# K061731: Medgraphics Ultima System

- Pathway: 510(k) (Special)
- Applicant: Medical Graphics Corp.
- Decided: Sep 6, 2006 after 78 days
- Product code: BZL (Computer, Oxygen-Uptake)
- Device class: 2
- Regulation: 21 CFR 868.1730
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K955432 (1996). 1 ancestor in all.
6 later devices descend from it; 2 cite it directly.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K955432: CPX, CCM, Cath with 15% CO2, Medical Graphics Corp. (1996) Summary page 1.

## Most influential descendants
- K071911: Cardiopulmonary Exercise Testing Option to Innocor (2007), 3 descendants of its own
- K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500) (2009), 2 descendants of its own
- K070858: Express Series (2007), 2 descendants of its own
- K200076: Breezing Med (2020), 0 descendants of its own
- K190561: NICU V'02 (2020), 0 descendants of its own

## Indications for use
The Ultima system uses the direct measurement of oxygen uptake to objectively and non-invasively assess cardiac and pulmonary function during exercise. The system can be used to screen for early signs of cardiac and pulmonary dysfunction; differentiate heart and lung disease; assess dyspnea complaints; classify patients according to severity of disease as a guide for patient management; establish an optimal exercise prescription and training program; evaluate the efficiency of prescribed therapy. The Ultima system uses the direct measurement of oxygen uptake and carbon dioxide production to provide nutritional assessment, to optimize nutritional supplements and quantify substrate utilization. The Ultima system can also provide direct Fick determination of cardiac output using real time oxygen uptake measurements.

Source page: https://510kreport.com/device/K061731
Methodology: https://510kreport.com/methodology