# K082045: Modification to Mcare 300 Vital Signs Monitor, Model 91220

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Medical, Inc.
- Decided: Aug 1, 2008 after 14 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 34 ancestors in all.
No later device cites it as a predicate yet.
0 of 35 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062095: Mcare 300 Vital Signs Monitor, Model 91220, Spacelabs Medical, Inc. (2006) Summary page 2.
- K032857: Press-Mate BX-10 Vital Sign Monitor, Colin Medical Instruments Corp. (2004) Summary page 2.

## Recalls of this device
- Apr 14, 2010 · Not classified · Z-3185-2011: There have been reports that the Spacelabs Medical Vital Signs Monitor, Model 91220, will not power up with AC power and will no longer charge the batteries.

## 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 CO 2. 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/K082045
Methodology: https://510kreport.com/methodology