# K102422: Spacelabs Medical Patient Monitors

- Pathway: 510(k) (Special)
- Applicant: Spacelabs Medical, Inc.
- Decided: Dec 7, 2010 after 104 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- 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 K842616 (1984). 3 ancestors in all.
3 later devices descend from it; 3 cite it directly.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K972282: Spacelabs Medical Pcis Patient Monitors, Spacelabs Medical, Inc. (1997) Summary page 1.

## Most influential descendants
- K160667: Anybattery C2 Rechargeable Battery (2017), 0 descendants of its own
- K120616: Spacelabs Healthcare Qube Compact Monitor (91390 (2012), 0 descendants of its own
- K112962: Spacelabs Healthcare Xprezzon Beside Monitor (9913930) (2011), 0 descendants of its own

## Recalls of this device
- Aug 26, 2014 · Class II · Z-2707-2014: The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally. The firm performed a retrospective analysis of all recalls sin
- Jul 8, 2011 · Not classified · Z-3032-2011: The clinician did not realize the monitor was in END CASE mode and was expecting audible alarms. Visual alarms continue to work normally.
- Mar 24, 2011 · Not classified · Z-2134-2011: The circuit that supplies backup power to the modules in the Medical Patient Monitor, Model 91387, is not working. If there is a power interruption, the three-minute backup may not be operational and 

## Indications for use
Spacelabs Healthcare patient monitors, functioning as either bedside or central monitors; passively display data generated by Spacelabs Healthcare parameter modules, Flexports interfaces, and other SDLC based products in the form of waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91367, 91369, 91370 and 91387, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO 2 , temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed. Spacelabs Healthcare patient monitors are intended to alert the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other physiologic monitors via Flexport interfaces. These devices determine a) when an alarm condition is violated; b) the alarm priority (i.e. high, medium or low); c) alarm limits; and d) when to initiate and terminate alarm notifications. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature. Spacelabs Healthcare patient monitors may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitors allow network-based applications to open windows and display information on other networked monitors. Spacelabs Healthcare patient monitors are also designed to communicate with a variety of external devices such as displays, network devices, serial devices, user input devices, audio systems, and local/remote recorders. Spacelabs Healthcare patient monitors are intended for use under the direct supervision of a licensed healthcare practitioner, or by personnel trained in proper use of the equipment in a hospital environment.

Source page: https://510kreport.com/device/K102422
Methodology: https://510kreport.com/methodology