# K061932: Bernoulli Management System (MS) Software

- Pathway: 510(k) (Traditional)
- Applicant: Cardiopulmonary Corp.
- Decided: Sep 14, 2006 after 69 days
- Product code: MSX (System, Network And Communication, Physiological Monitors)
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
14 later devices descend from it; 2 cite it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Most influential descendants
- K071047: Masimo Patient Safety Net (2007), 7 descendants of its own
- K110521: Everon Central Display Station (CDS) (2011), 6 descendants of its own
- K121885: Earlysense Central Display System (2012), 5 descendants of its own
- K102974: Intellisphere Event Managment System Rel. 10.00 (2011), 5 descendants of its own
- K151006: EarlySense Central Display Station (CDS) (2015), 4 descendants of its own

## Indications for use
The Bernoulli MS software is intended to be used on a central monitoring station on patients using supported devices in a hospital or hospital type environment. It is used to provide a secondary display of ventilator, respiratory monitor, and/or multi parameter monitor data (ECG, respiratory rate, pulse oximetry, ETCO 2, blood pressure, cardiac output, temperature and associated derived outputs) to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli MS is intended to supplement and not replace any part of the current device monitoring procedures.

Source page: https://510kreport.com/device/K061932
Methodology: https://510kreport.com/methodology
