# K050605: Spacelabs Medical Multiparameter Module 91496

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Medical, Inc.
- Decided: May 3, 2005 after 54 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- 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: 6 generations back to K962603 (1997). 25 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 27 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050175: Spacelabs Medical Multiparameter Module 91496, Spacelabs Medical, Inc. (2005). Our reading of the summary gave K051175, FDA’s number for Civ-OB Obstrical Monitoring Software Application (Civent Communications, Ltd.), decided Feb 17, 2006, after this device. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spacelabs Medical Integrated Multiparameter Module 91496 with Option…”.
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496, Spacelabs Medical, Inc. (1998) Summary page 1.
- K033296: Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model Rad-5V, Masimo Corp. (2004) Summary page 1.

## Most influential descendants
- K103142: Spacelabs Multi-Parameter Module (2011), 0 descendants of its own

## Recalls of this device
- Jan 3, 2007 · Not classified · Z-0523-2007: Potential for modules to reset, alarms returning to default settings, invasive pressure losing its labels and zero calibration and Sp02 alarm limits being frozen. This can result in delay in treatment

## 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. Specific to the physiologic parameter being monitored, accessories may be applied externally to the chest and limbs or invasively into the blood stream. Frequency as directed by physician. 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/K050605
Methodology: https://510kreport.com/methodology