# K153654: Sentry WEB SmartInterp

- Pathway: 510(k) (Traditional)
- Applicant: Carefusion Germany 234 GmbH
- Decided: Sep 16, 2016 after 270 days
- Product code: DQK (Computer, Diagnostic, Programmable)
- Device class: 2
- Regulation: 21 CFR 870.1425
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K002074 (2000). 23 ancestors in all.
No later device cites it as a predicate yet.
1 of 24 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K122699: Sentrysuite Product Line, Carefusion Germany 234 GmbH (2012) Summary page 5.
- K150810: Vyntus / SentrySuite Product Line, Carefusion Germany 234 GmbH (2015) Summary page 5.
- K012020: Respievents Software IS Event Data Processing Sofware for a PC, Non-Invasive Monitoring Systems, Inc. (2001) Summary page 5.

## Indications for use
Sentry WEB SmartInterp is a medical software which is intended to be used as an aid in the evaluation and diagnosis of already measured cardiopulmonary data. Access to data will be realized via network or internet with assigned access rights. Patient population is not assigned as it is defined by the measuring devices itself.

Source page: https://510kreport.com/device/K153654
Methodology: https://510kreport.com/methodology