# K031124: Polaris 95000-a Bedside/Transport Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Datex-Ohmeda, Inc.
- Decided: Dec 4, 2003 after 240 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 2 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K941165 (1994). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 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 1.
- K941165: Comet Capnograph Module, Spacelabs, Inc. (1994) Summary page 1.

## Recalls of this device
- May 12, 2011 · Not classified · Z-2573-2011: Capnography Module, Model 91517, resets 20 seconds after power failure, instead of after three minutes as specified. This reset clears the RAM and the module returns to default settings.
- Jul 20, 2005 · Not classified · Z-0517-06: The transducer used to compensate for pressure changes was mounted backwards on the printed circuit board assembly. The module will not compensate for pressure changes and CO2 readings will be inaccur

## Indications for use
The Model 95000-A Bedside/Transport Monitor is used at the patient's bedside to actively acquire, analyze, monitor and display a variety of clinical parameters (in clinically relevant formats) for adults, pediatric or neonatal patients. The Model 95000-A Bedside/Transport Monitor is designed for use by a healthcare professional in a hospital, healthcare facility (ie, clinic), or intra-hospital transport. This product is not designed for home use or for use in transport vehicles. The Model 95000-A Bedside/Transport Monitor supports product configurations with almost any combination of clinical parameters that provide the following: * A means for continuous monitoring of: * Electrocardiographic signals in order to detect: * Normal cardiac rhythms, including life-threatening events such as high and low heart rates, asystole and ventricular fibrillation. * (Adult patients only) Additional abnormal cardiac rhythms, such as ventricular runs and tachycardia, and ST segment deviations. * Respiratory effort in order to detect abnormal respiration events such as high and low respiration rates and episodes or apnea. * Invasive blood pressure in order to detect abnormal events such as high and low blood pressure. * Pulse oxygen saturation in order to detect desaturation due to abnormal pulmonary or circulatory functions. * Temperature in order to detect abnormal events such as high and low temperatures. - Carbon dioxide. * Oxygen. · A means for episodic monitoring of: * Non-invasive blood pressure signals to detect abnormal events such as high and low blood pressure. * (Adult patients only) Various hemodynamic values to detect abnormal cardiac flow (CO) values.

Source page: https://510kreport.com/device/K031124
Methodology: https://510kreport.com/methodology