# K051038: 506 Patient Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Ciriticare Systems, Inc.
- Decided: Aug 12, 2005 after 109 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: 2 generations back to K944860 (1995). 2 ancestors in all.
4 later devices descend from it; 2 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K022435: 507EL Vital Signs Monitor, Criticare Systems, Inc. (2002) Summary page 1.

## Most influential descendants
- K101259: V-Trust TD-8002 Multi-Parameter Spot-Check Monitor Model TD-8002 (2010), 1 descendant of its own
- K091050: 506CN Patient Monitor (2009), 1 descendant of its own
- K172221: VTRUST Vital Signs Monitor, Model: TD-2300; FORA Vital Signs Monitor, Model: VSM100 (2018), 0 descendants of its own
- K101602: Vital Signs Monitor (2010), 0 descendants of its own

## Indications for use
The 506 Patient monitor interprets and displays real time physiological data of the patient including numerical data. The 506 is configured to monitor Noninvasive BP (NIBP), SpO,, and Temperature. For each patient vital parameter, the 506 will be capable of providing limit alarms and alerts, printing of strip chart recordings and storing data trends for retrospective review. The 506 monitor utilizes existing core technologies from the predicate 507EL monitor for patient monitoring of NIBP, SpO,, and Temperature. Temperature measurement is provided by Kendall's Filac FasTemp module, which has been integrated into the 506 monitor. This temperature measurement technology allows predictive or continuous temperature measurement on adult or pediatric patients in oral, axillar, or rectal placements. SpO2 can optionally be provided by Nellcor's SpO2 module. 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/K051038
Methodology: https://510kreport.com/methodology