# K071911: Cardiopulmonary Exercise Testing Option to Innocor

- Pathway: 510(k) (Traditional)
- Applicant: Innovision A/S
- Decided: Sep 7, 2007 after 58 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 30 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 34 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051907: Innocor, Innovision A/S (2006) Summary page 1.
- K061731: Medgraphics Ultima System, Medical Graphics Corp. (2006) Summary page 2.

## Most influential descendants
- K083879: Innocor Ergospirometry System (INN00010), the Basic Innocor Including Breath-by-Breath System (INN00400), Nibp (INN00500) (2009), 2 descendants of its own
- K190561: NICU V'02 (2020), 0 descendants of its own
- K102047: Lci Option for Innocor (2011), 0 descendants of its own

## Indications for use
A cardiopulmonary exercise testing option is available for Innocor. This option provides breath-by-breath measurements of flow, oxygen uptake and carbon dioxide production. It is intended to measure oxygen uptake (metabolic rate) and related parameters to objectively and non-invasively assess cardiac and pulmonary function at rest and during exercise. With the cardiopulmonary exercise testing option, Innocor provides values for: Main metabolic parameters: * Oxygen uptake * Carbon dioxide excretion * Expiratory minute ventilatidn Calculated/derived parameters: * Oxygen uptake per kg * Respiratory exchange ratio * Alveolar ventilation * Anatomical dead space (Fowler dead space) * Tidal volume * Respiratory rate * End-tidal concentration of oxygen * End-tidal concentration of carbon dioxide * Expiratory quotient / ventilatory equivalent for oxygen * Expiratory quotient / ventilatory equivalent for carbon dioxide And the following calculated parameters after an incremental exercise test: * Anaerobic threshold * Respiratory compensation * Rest values * Values at AT point * Values at max exercise

Source page: https://510kreport.com/device/K071911
Methodology: https://510kreport.com/methodology