# K952912: Spacelabs Medical Integrated Multi-Parameter Module

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Apr 2, 1997 after 646 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: 1 generation back to K882609 (1989). 7 ancestors in all.
150 later devices descend from it; 1 cites it directly.
0 of 158 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K945429: Spacelabs Medical Expansion Module (Model 90352), Spacelabs Medical, Inc. (1995). Cleared while this submission was under review Summary page 1.
- K942058: Spacelabs Medical Ecg Module (Model 90492), Spacelabs Medical, Inc. (1995) Summary page 1.
- K925510: Model 90478 & 90479 Telemetry Rec. Module&Housing, Spacelabs Medical, Inc. (1994). Our OCR of the scanned summary read K922510, which is not a number in FDA’s lists. Corrected to the number one digit away whose FDA name carries the summary’s words for the device, “Spacelabs Medical 90478 Telemetry Receiver”.
- K941167: Non-Invasive Blood Pressure (Nibp) Monitor (Model 90553), Spacelabs Medical, Inc. (1994) Summary page 1.
- K913695: Nellcor (R) N-180 Pulse Oximeter, Nellcor, Inc. (1991) Summary page 1.
- K882609: Models M1175A & M1176A Component Monitoring System, Waltham Div. Hewlett Packard (1989) Summary page 1.
- K900032: Model M1175A/M1176A with ST Segment Monitoring, Hewlett-Packard Co. (1990) Summary page 1.

## Cited in the summary but kept off the family tree
- K901209: Model 90489 Pulse Oximeter Module, Spacelabs, Inc. (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree
- K900598: Tramscope System, Marquette Electronics, Inc. (1990). Not matched in our reading of the summary (scans can blur digits), so it is kept off the family tree

## Most influential descendants
- K972502: Spacelabs Medical Integrated Multiparameter Module 90496 (1998), 149 descendants of its own
- 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

## Indications for use
The Spacelabs Medical Integrated Multi-Parameter Module is intended for use as a ECG monitor and an arrhythmia detector, which monitors the electrocardiogram and is designed to produce a visible and audible signal (via a Spacelabs Medical PCMS monitor) when an arrhythmia, such as premature ventricular contraction, ventricular fibrillation, asystole, high/low heart rates, ventricular runs, or tachycardia, exists. In addition, ST segment deviations are detected. The Spacelabs Medical Integrated Multi-Parameter Module is also intended for use as a non-invasive blood pressure system, a pulse oximeter, and a monitor of respiratory effort. The Spacelabs Medical Integrated Multi-Parameter Module is intended for use on both adult and neonatal patient populations in all clinical settings. The Spacelabs Medical Integrated Multi-Parameter Module is not intended for home use.

Source page: https://510kreport.com/device/K952912
Methodology: https://510kreport.com/methodology