# K242809: Ascent Cardiorespiratory Diagnostic Software

- Pathway: 510(k) (Traditional)
- Applicant: Medical Graphics Corporation
- Decided: Oct 17, 2024 after 30 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: 4 generations back to K954140 (1995). 11 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181912: Ascent Cardiorespiratory Diagnostic Software, Medical Graphics Corporation (2019) Summary page 5.
- K133925: Vyntus/ Sentrysuite Product Line, Carefusion Germany 234 GmbH (2014) Summary page 5.

## Most influential descendants
- K260242: CPETWise Platform (2026), 0 descendants of its own

## Indications for use
Ascent Cardiorespiratory Diagnostic Software is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, and cardiopulmonary testing (CPET) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece or a mask. The results of the test can be viewed on-line with the help of a computer screen and can be printed after the test. The test results can be saved for further referral or report generation purposes. For use of the Bronchial Challenge option, the medical director of the laboratory, physician, or person appropriately trained to treat acute bronchoconstriction, including appropriate use of resuscitation equipment, must be close enough to respond quickly to an emergency. The product can be utilized for patients from 4 years old and older as long as they can cooperate in the performance -- no special limit to patient's sex or height. Measurements will be performed under the direction of a physician in a hospital environment, physician's office or similar settings.

Source page: https://510kreport.com/device/K242809
Methodology: https://510kreport.com/methodology