# K980094: Modification to the Oxyconalpha

- Pathway: 510(k) (Traditional)
- Applicant: Erich Jaeger B.V.
- Decided: Jul 28, 1998 after 200 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
4 later devices descend from it; 2 cite it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K993641: Metalyzer, Model 2; Metalyzer, Model 3 (2000), 3 descendants of its own
- K090722: Shape-HF Cardiopulmonary Exercise Testing System (2009), 2 descendants of its own
- K150888: Shape-HF Cardiopulmonary Testing System (2016), 0 descendants of its own
- K093080: Metaphor Metabolic Monitor (2010), 0 descendants of its own

## Indications for use
The OxyconAlpha is used as a predictive pulmonary function value calculator (Product code BTY). It i a software-driven, active medical device for investigational exercise measurements. It measures the human response to increasing workloads with emphasis on the gas exchange parameters. Measurements include ventilation, oxygen uptake, carbon dioxide production and derived parameters. It is the intention to determine on patients a cardiopulmonary limitation and to test on sport athlets their training level. The different load levels for both groups can be generated over a bicycle ergometer or over a treadmill. The patient population is age 4 and older. The environment of use is indoor. The OxyconAlpha interfaces to a testsubject via mouthpiece or a face mask. The OxyconAlpha interfaces to peripheral equipment and is therefore available in a variety of configurations from a standard controlled ergospirometry unit to a fully expandable laboratory system with blood pressure monitor, treadmill and ergometer. The OxyconAlpha interacts with the ECG signal (recorded by another device) only to the extent of extracting the patient's heart rate from the ECG signal. Other uses such as displaying or further analyzing the ECG waveforms are not included in the present submittal. The device is not intended for use as a diagnostic pulmonary-function interpretation calculator.

Source page: https://510kreport.com/device/K980094
Methodology: https://510kreport.com/methodology