# K133925: Vyntus/ Sentrysuite Product Line

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion Germany 234 GmbH
- Decided: Aug 22, 2014 after 242 days
- Product code: BZC (Calculator, Pulmonary Function Data)
- Device class: 2
- Regulation: 21 CFR 868.1880
- 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 K954140 (1995). 9 ancestors in all.
8 later devices descend from it; 2 cite it directly.
1 of 18 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K072323: Masterscreen & Oxycon CPX, Viasys Healthcare GmbH (2007) Summary page 5.
- K992214: Oxycon Pro, Erich Jaeger B.V. (2000) Summary page 5.
- K122699: Sentrysuite Product Line, Carefusion Germany 234 GmbH (2012) Summary page 5.

## Most influential descendants
- K150810: Vyntus / SentrySuite Product Line (2015), 5 descendants of its own
- K242809: Ascent Cardiorespiratory Diagnostic Software (2024), 1 descendant of its own
- K181524: Vyntus ONE with CART, Vyntus ONE PFT only with CART, Vyntus ONE with adjustable CART, Vyntus ONE PFT only with adjustable CART (2018), 1 descendant of its own
- K260242: CPETWise Platform (2026), 0 descendants of its own
- K183567: Vyntus/SentrySuite Product Line (2019), 0 descendants of its own

## Indications for use
The Vyntus/SentrySuite product line is intended to be used for measurements, data collection and analysis of lung function (PFT) and cardio-pulmonary (CPET) parameters, aiding in the diagnosis of related conditions. The results of the test can be viewed online with the help of a computer screen and can be printed after the test. The test results can be saved for future reference or report generation purposes. The products can be utilized with patients age 4 years and older as long as they can cooperate in the performance - no special limit to patient’s sex or height exists. Measurements will be performed under the direction of a physician in a hospital environment, physician’s office or similar setting (professional healthcare facilities).

Source page: https://510kreport.com/device/K133925
Methodology: https://510kreport.com/methodology