# K974200: Orca Cardiopulmonary Exercise Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Orca Diagnostics Corp.
- Decided: Jul 21, 1998 after 253 days
- Product code: BZM (Calculator, Pulmonary Function Interpretor (Diagnostic))
- Device class: 2
- Regulation: 21 CFR 868.1900
- 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 K923209 (1993). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K923209: Medgraphics Exercise Consult, Medical Graphics Corp. (1993) Summary page 1.
- K942211: VMAX229 Series Pulmonary/Metabolic Systems, Sensor Medics Corp. (1994) Summary page 1.

## Indications for use
The ORCA System is indicated for use in exercise tests where the collection and analysis of gas exchange and extraction of pulse rate information from ECG during exercise stress testing is needed. Further, the device will suggest interpretive statements based on the results of the analysis and the reasons for the test termination. The intended patients are adults and children and the intended environment of use is indoors.

Source page: https://510kreport.com/device/K974200
Methodology: https://510kreport.com/methodology