# K260242: CPETWise Platform

- Pathway: 510(k) (Traditional)
- Applicant: Medibyt, Ltd.
- Decided: Aug 20, 2026 after 206 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: 5 generations back to K954140 (1995). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K242809: Ascent Cardiorespiratory Diagnostic Software, Medical Graphics Corporation (2024) Summary page 5.

## Indications for use
The CPETWise Platform is a software device that is intended to be used for already measured cardiopulmonary data for the analysis of cardiopulmonary testing (CPET) parameters and lung function (PFT) parameters, aiding in the diagnosis of related conditions. The test results can be viewed online using a computer screen and printed after the test. The test results can be saved for further referral or report generation purposes. The device can be utilized for patients aged 18 and older as long as they can cooperate in the CPET performance. The CPETWise platform is intended to be used in healthcare environments such as a hospital, a physician’s office, or similar settings.

Source page: https://510kreport.com/device/K260242
Methodology: https://510kreport.com/methodology