# K091050: 506CN Patient Monitor

- Pathway: 510(k) (Special)
- Applicant: Criticare Systems, Inc.
- Decided: May 27, 2009 after 44 days
- Product code: DRT (Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm))
- 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
Longest line of descent: 3 generations back to K944860 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K051038: 506 Patient Monitor, Ciriticare Systems, Inc. (2005)

## Most influential descendants
- K101602: Vital Signs Monitor (2010), 0 descendants of its own

## Indications for use
This system is intended to monitor physiological parameters of patients within any healthcare environment. The user, responsible to interpret the monitored data made available, will be a professional health care provider. Physiological data, system alarms and patient data analysis will be available to the care provider from the monitor.

Source page: https://510kreport.com/device/K091050
Methodology: https://510kreport.com/methodology