# K062095: Mcare 300 Vital Signs Monitor, Model 91220

- Pathway: 510(k) (Abbreviated)
- Applicant: Spacelabs Medical, Inc.
- Decided: Sep 29, 2006 after 67 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 7 generations back to K962603 (1997). 26 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013046: Cosmos System, Spacelabs Medical, Inc. (2002) Summary page 2.
- K031740: VSM - Vital Signs Monitor, Model 53000 Series, Welch Allyn Protocol, Inc. (2003) Summary page 2.
- K042601: Capnostat 5, Respironics Novametrix, Inc. (2004) Summary page 2.
- K053174: Loflo C5 CO2 Sensor, Respironics Novametrix, LLC (2006) Summary page 2.

## Cited in the summary but kept off the family tree
- K012740: Clearfil AP-X, Kuraray Medical, Inc. (2001). Our reading of the summary gave K012740, FDA’s number for Clearfil AP-X (Kuraray Medical, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Nellcor N-595”. Kept off the family tree.

## Most influential descendants
- K100217: Lucon M-Series Patient Monitor, Models M20 and M30 (2010), 1 descendant of its own
- K112190: Patient Monitor (2011), 0 descendants of its own
- K082045: Modification to Mcare 300 Vital Signs Monitor, Model 91220 (2008), 0 descendants of its own

## Indications for use
The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is indicated for use in adult, pediatric and neonate patient populations wherever there is a need for the monitoring of ECG, respiration, invasive or noninvasive blood pressures, body temperature, functional arterial oxygen saturation, or expired or minimum inspire COD. The Spacelabs Medical mCARE 300, Model 91220, Vital Signs Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.

Source page: https://510kreport.com/device/K062095
Methodology: https://510kreport.com/methodology