# K972282: Spacelabs Medical Pcis Patient Monitors

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Medical, Inc.
- Decided: Sep 25, 1997 after 99 days
- Product code: DSI (Detector And Alarm, Arrhythmia)
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 4 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K842616 (1984). 2 ancestors in all.
124 later devices descend from it; 3 cite it directly.
0 of 127 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K842616: Spacelabs Alpha PC Patient Computer, Spacelabs, Inc. (1984) Summary page 1.
- K930095: Spacelabs Medical Patient Monitor, Spacelabs Medical, Inc. (1993) Summary page 1.

## Cited in the summary but kept off the family tree
- K832734: Kemtek 400 Ria Gamma Counter, Kemble Instruments, Inc. (1983). Our OCR of the scanned summary read K832734, FDA’s number for Kemtek 400 Ria Gamma Counter (Kemble Instruments, Inc.). Its FDA name has none of the distinctive words the summary uses for the device it names, “Universal Clinical Workstation (UCW)”. Kept off the family tree. Summary page 1.

## 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
- Sep 17, 2010 · Not classified · Z-3036-2011: Monitor may reset repeatedly which can result in a loss of patient monitoring for several minutes. Cause is a software problem.
- Nov 6, 2009 · Not classified · Z-0647-2010: Potential for monitor to shut down and not being able to power on again.
- Nov 6, 2009 · Not classified · Z-0648-2010: Potential for monitor to shut down and not being able to power on again.
- Nov 6, 2009 · Not classified · Z-0649-2010: Potential for monitor to shut down and not being able to power on again.

## Indications for use
PC1 Monitor - The Spacelabs Medical PC1 monitor is intended for use in any hospital environment as a bedside or central station patient monitor. The PC1 monitor is capable of displaying any of the patient parameters currently available through Spacelabs Medical. Universal Clinical Workstation (UCW) - The Universal Clinical Workstation (UCW) is intended for use in any hospital environment as a bedside or central station patient monitor. The UCW is capable of displaying any of the patient parameters currently available through Spacelabs Medical. PC Scout Monitor - The PC Scout is a lightweight, battery-powered or line powered monitor that is fully compatible and used in either bedside operation or in patient transport. The PC Scout is capable of displaying any of the patient parameters currently available through Spacelabs Medical. General Spacelabs Medical PCIS Patient Monitor Intended Use Statement Spacelabs Medical PCIS patient monitors passively display data generated from Spacelabs Medical patient parameter modules, Flexport interfaces, gas analyzers, and other SDLC based products. Spacelabs Medical PCIS patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the PCIS patient monitors allow network-based applications to open windows and display information on other networked monitors. PCIS patient monitors is intended to sound various alarm tones that are generated by the specific PCIS patient parameter modules. Each patient parameter module determines (a) when an alarm condition is violated: (b) the alarm priority (i.e. high, medium or low); (c) alarm limits; and (d) when to generate and terminate alarms. PCIS patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Medical PCIS patient monitors are designed to communicate with a variety of external devices such as display devices, network devices, serial devices, user input devices, audio system, local/remote recorders and Spacelabs Medical patient parameter modules. In all applications, Spacelabs Medical PCIS patient monitors provide access to that data on the Spacelabs Medical network either via hardwire or wireless transmission.. Through this network, a patient’s data may be displayed at the bedside monitor, central station or a clinical information system.

Source page: https://510kreport.com/device/K972282
Methodology: https://510kreport.com/methodology