# K050175: Spacelabs Medical Multiparameter Module 91496

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Medical, Inc.
- Decided: Mar 4, 2005 after 37 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 5 generations back to K962603 (1997). 21 ancestors in all.
2 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496, Spacelabs Medical, Inc. (1998) Summary page 1.
- K012891: Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables (Aka Accessories), Nellcor Puritan Bennett, Inc. (2002) Summary page 1.

## Most influential descendants
- K050605: Spacelabs Medical Multiparameter Module 91496 (2005), 1 descendant of its own
- K103142: Spacelabs Multi-Parameter Module (2011), 0 descendants of its own

## Indications for use
Conditions to be screened, monitored, treated or diagnosed. Patient conditions indicated by abnormalities in various physiologic parameters, including ECG waveform, respiratory effort, invasive and noninvasive blood pressure measurements, temperature, cardiac output, and pulse oximeter (SpO2) readings. Prescription use only. Yes. Caution statement is provided in the introductory page of the Patient Care Management System which includes the operating instructions for this Module. Parts of body applied to. Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream. Frequency of use. Frequency as directed by physician. Physiological purpose. In conjunction with clinical findings, a screening and diagnostic tool for use in: assessing electrical activity of the heart in order to detect abnormal cardiac rhythms, including life threatening events such as high and low heart rates, asystole and ventricular fibrillation as well as, in adults, the detection of rhythms such as ventricular runs, tachycardia, and ST segment deviations; monitoring respiratory effort to detect abnormal respiration events such as high and low respiration rates and episodes of apnea; continuous monitoring of invasive pressure signals to detect abnormal events such as high and low pressure; episodic monitoring of noninvasive pressure signals to detect abnormal events such as high and low pressure; continuous monitoring of temperature signals to detect abnormal events such as high and low body temperature; monitoring of the patient's pumping ability of the heart and various hemodynamic values to detect abnormal flow volumes; and noninvasive, continuous monitoring of pulse oxygen saturation signals in order to detect desaturation due to abnormal pulmonary/circulatory functions.

Source page: https://510kreport.com/device/K050175
Methodology: https://510kreport.com/methodology