# K192584: BEACON Caresystem Model 00002144

- Pathway: 510(k) (Traditional)
- Applicant: Mermaid Care A/S
- Decided: Dec 18, 2019 after 90 days
- Product code: BZK (Spirometer, Monitoring (W/Wo Alarm))
- Device class: 2
- Regulation: 21 CFR 868.1850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 9 generations back to K902859 (1991). 41 ancestors in all.
No later device cites it as a predicate yet.
4 of 42 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K103578: Philips NM3 Respiratory Monitor with Ventassist, Respironics Novametrix, LLC (2011) Summary page 4.

## Indications for use
The intended use of the BEACON Caresystem is to provide • respiratory mechanics monitoring in adult patients in the Intensive Care Unit (ICU) • on-demand ventilator-dependent open-loop advice in mechanically ventilated adult patients as prescribed by the clinician Patients should be hemodynamically stable. The device is intended for use by properly trained clinicians. BEACON Caresystem is for prescription use, only.

Source page: https://510kreport.com/device/K192584
Methodology: https://510kreport.com/methodology