# K972502: Spacelabs Medical Integrated Multiparameter Module 90496

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: May 28, 1998 after 329 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 2 generations back to K933143 (1994). 11 ancestors in all.
149 later devices descend from it; 6 cite it directly.
0 of 161 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K952912: Spacelabs Medical Integrated Multi-Parameter Module, Spacelabs Medical, Inc. (1997) Summary page 2.
- K945429: Spacelabs Medical Expansion Module (Model 90352), Spacelabs Medical, Inc. (1995) Summary page 2.
- K942058: Spacelabs Medical Ecg Module (Model 90492), Spacelabs Medical, Inc. (1995) Summary page 2.
- K962970: Spacelabs Medical 12-Lead Diagnostic Ecg Analysis Option, Spacelabs Medical, Inc. (1997) Summary page 2.
- K896920: Sidewinder 40CC DL Intra-Aortic Balloon Catheter, Boston Scientific Corp (1990) Summary page 2.

## Most influential descendants
- K993531: Passport 2 Vital Signs Monitor, Model 0998-00-0170-XX (2000), 119 descendants of its own
- K032733: PM-8000 Patient Monitor, Model 8000 (2004), 88 descendants of its own
- K043348: Modification to PM-8000 Patient Monitor (2005), 87 descendants of its own
- K020550: Passport 2 with View 12 Ecg Analysis Module Model # 0998-00-0170-XXXX (2002), 75 descendants of its own
- K053234: PM-9000 Express Patient Monitor (2006), 71 descendants of its own

## Recalls of this device
- Jul 22, 2008 · Not classified · Z-2343-2008: Potential for module to fail to obtain a NIBP reading on hypertension patients.
- Jul 22, 2008 · Not classified · Z-2342-2008: Potential for module to fail to obtain a NIBP reading on hypertension patients.
- Jul 2, 2008 · Not classified · Z-2314-2008: Intermittent contact of temperature probe adaptors can cause a loss of temperature monitoring which can cause a delay in care when an alarm is missed.

## Indications for use
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 (Sp02) 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 apneg; 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/K972502
Methodology: https://510kreport.com/methodology