# K113813: Sentrysuite Product Line

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion Germany 234 GmbH
- Decided: May 10, 2012 after 139 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: 2 generations back to K954140 (1995). 5 ancestors in all.
No later device cites it as a predicate yet.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K111053: Sentrysuite Product Line, Carefusion Germany 234 GmbH (2011) Summary page 2.
- K072061: Masterscreen PFT, Masterscreen PFT CT, Masterscreen PFT Body, Viasys Healthcare GmbH (2008) Summary page 2.

## Indications for use
The SentrySuite Product line is intended to be used for measurements, data collection and analysis of lung function (PFT) parameters, aiding in the diagnosis of related conditions. All the measurements are performed via a mouthpiece, a mask or nasal adapters. 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 further referral or report generation purposes. Use of the Option Bronchial Challenge requires the supervision of a physician familiar with emergency medicine. The products can be utilized for patients from 4 years on 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/K113813
Methodology: https://510kreport.com/methodology