# K122146: Xhibit Central Station, Model 96102

- Pathway: 510(k) (Traditional)
- Applicant: Spacelabs Healthcare
- Decided: Apr 22, 2013 after 277 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 5 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K011093 (2001). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050742: M3290A Intellivue Information Center Software Release G.00, Philips Medical Systems (2005) Summary page 2.

## Recalls of this device
- Jun 4, 2026 · Class II · Z-2916-2026: Due to off-the-shelf display port component that has audio/video failures
- Aug 30, 2019 · Class II · Z-2261-2020: The firm received reports of loss of audio alarm after a power failure or cable disconnection. The loss of audio for a telemetry patient could delay the recognition of an alarm condition.
- Oct 18, 2016 · Class II · Z-0332-2017: The firm received reports of telemetry SpO2 numerics dropping off the Xhibit Central display. Desaturation, high, and low limit alarms work normally.
- Aug 25, 2016 · Class II · Z-2885-2016: The firm received multiple reports of Xhibit Telemetry System going offline or locking up. In addition, short-duration asystole alarms may not display an audio and visual alarm as reported from a sing
- Feb 26, 2016 · Class II · Z-1092-2016: The firm has received one report of values for patient height and weight being switched when input at the Xhibit Central Station, Model 96102, causing a bedside monitor Body Surface Area (BSA) calcula

## Indications for use
The Spacelabs Healthcare Xhibit Central Station, Model 96102 intended use is to provide clinicians with central monitoring of adult, pediatric and neonatal patient data of patients connected to networked Spacelabs Healthcare patient monitors and telemetry transmitters: Data includes physiological waveforms and calculations, cardiac arrhythmia and ST data, and patient demographic information to monitor adequacy of treatment or to exclude causes of symptoms. The Spacelabs Healthcare Xhibit Central Station, Model 96102 is a prescription device intended for use under the direct supervision of a licensed healthcare professional.

Source page: https://510kreport.com/device/K122146
Methodology: https://510kreport.com/methodology