# K011861: Bernoulli Ventilator Management System

- Pathway: 510(k) (Traditional)
- Applicant: Cardiopulmonary Corp.
- Decided: Nov 6, 2001 after 145 days
- Product code: MOD (Accessory To Continuous Ventilator (Respirator))
- Device class: 2
- Regulation: 21 CFR 868.5895
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 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
- K161411: Care Cycle Connect Application (2017), 1 descendant of its own
- K260051: CorVision® (91-205-Z0014) (2026), 0 descendants of its own
- K052244: Iisis, Version 1.0 (2005), 0 descendants of its own

## Indications for use
The Bernoulii VMS software is intended to be used on a central monitoring station on mechanically ventilated patients in a hospital or hospital type environment. It is used to provide a secondary display of the ventilator data to the central station, and to provide remote monitoring and alarm surveillance. The Bernoulli VMS is intended to supplement and not replace any part of the current device monitoring procedures.

Source page: https://510kreport.com/device/K011861
Methodology: https://510kreport.com/methodology