# K993641: Metalyzer, Model 2; Metalyzer, Model 3

- Pathway: 510(k) (Traditional)
- Applicant: Cortex Biophysik GmbH
- Decided: Dec 14, 2000 after 413 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
Longest line of descent: 1 generation back to K980094 (1998). 1 ancestor in all.
3 later devices descend from it; 1 cites 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)
- K980094: Modification to the Oxyconalpha, Erich Jaeger B.V. (1998) Summary page 1.

## Most influential descendants
- 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 CORTEX METALYZER pulmonary function stationary test system is a device which monitors the cardio-respiratory functions during stress testing, rehabilitation, sports medicine and other related activities. The METALYZER system provides predictive pulmonary function values using the monitored and derived parameters. This device is for use in a laboratory or facility setting and may be used with adults and children over the age of 14 years.

Source page: https://510kreport.com/device/K993641
Methodology: https://510kreport.com/methodology