# K150888: Shape-HF Cardiopulmonary Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Shape Medical Systems, Inc.
- Decided: Jan 21, 2016 after 294 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: 3 generations back to K980094 (1998). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090722: Shape-HF Cardiopulmonary Exercise Testing System, Shape Medical Systems, Inc. (2009) Summary page 4.
- K980094: Modification to the Oxyconalpha, Erich Jaeger B.V. (1998) Summary page 5.

## Indications for use
The Shape-HF™ Cardiopulmonary Testing System is a pulmonary function stationary testing system intended to be used to monitor cardiopulmonary functions during stress testing, rehabilitation, sports medicine, and other related procedures for which cardiopulmonary gas exchange measurements are medically indicated. The System provides predictive pulmonary function values that are calculated based on the data obtained during testing. The System can be used on adults and children older than 14 years old in a laboratory or clinical facility setting.

Source page: https://510kreport.com/device/K150888
Methodology: https://510kreport.com/methodology