# K090722: Shape-HF Cardiopulmonary Exercise Testing System

- Pathway: 510(k) (Traditional)
- Applicant: Shape Medical Systems, Inc.
- Decided: Mar 31, 2009 after 12 days
- Product code: BTY (Calculator, Predicted Values, Pulmonary Function)
- Device class: 2
- Regulation: 21 CFR 868.1890
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K980094 (1998). 2 ancestors in all.
2 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)
- K993641: Metalyzer, Model 2; Metalyzer, Model 3, Cortex Biophysik GmbH (2000) Summary page 1.

## Most influential descendants
- K150888: Shape-HF Cardiopulmonary Testing System (2016), 0 descendants of its own
- K093080: Metaphor Metabolic Monitor (2010), 0 descendants of its own

## Recalls of this device
- Dec 23, 2014 · Class II · Z-1060-2015: This recall has been initiated because use of the impacted DPIs could result in erroneous testing results potentially leading to incorrect diagnosis and incorrect treatment. The magnitude of error for
- May 28, 2014 · Class II · Z-2051-2014: Shape Medical has initiated a correction due to a mandatory software upgrade for the Shape HF Cardiopulmonary Testing System prior to use of the impacted DPI lot numbers. Use of the incorrect software

## Indications for use
The Shape-HFTM 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/K090722
Methodology: https://510kreport.com/methodology