510(k) · Cleared
Recalled · Class II · 2026Xhibit Central Station, Model 96102
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Healthcare · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 22, 2013 as substantially equivalent to K050742 (Philips Medical Systems, 2005) after a 277-day review. Its family tree reaches back 3 generations to 2001. It has been recalled 5 times.
- Decided
- Apr 22, 2013
- Review
- 277 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 5
- Predicates
- 1
Its longest line of descent runs back 3 generations to K011093 (2001). No later device cites it as a predicate yet.
- Root · 3 generations backK011093 Agilent Information Center Software for M3150,M3151,M3153 and M3154Agilent Technologies, Inc. · 2001 · Recalled
- 2 generations backK031403 M3290A Intellivue Information Center Software Release E.1Philips Medical Systems, Inc. · 2003
- 1 generation backK050742 M3290A Intellivue Information Center Software Release G.00Philips Medical Systems · 2005
- This deviceK122146 Xhibit Central Station, Model 96102Spacelabs Healthcare · 2013
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K011093 | Agilent Information Center Software for M3150,M3151,M3153 and M3154 | Agilent Technologies, Inc. | 2001 | 4 |
| −2 | K031403 | M3290A Intellivue Information Center Software Release E.1 | Philips Medical Systems, Inc. | 2003 | — |
| −1 | K050742 | M3290A Intellivue Information Center Software Release G.00 | Philips Medical Systems | 2005 | — |
| 0 (this device) | K122146 | Xhibit Central Station, Model 96102 | Spacelabs Healthcare | 2013 | — |
Sources: FDA 510(k) database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in MHX? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | K050742 | M3290A Intellivue Information Center Software Release G.00Summary page 2…Predicate Equivalent Devices: 510(k) Number Manufacturer/Model Spacelabs Healthcare K050742 Philips Medical Systems Xhibit Central Station, Intell… | 2005 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 4, 2026 | Class II | Z-2916-2026 | Unknown/Undetermined by firm | Due to off-the-shelf display port component that has audio/video failures |
| Aug 30, 2019 | Class II | Z-2261-2020 | Software Manufacturing/Software Deployment | 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 | Software design | 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 | Software design | 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 single Canadian hospital. |
| Feb 26, 2016 | Class II | Z-1092-2016 | Software in the Use Environment | 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) calculation to be in error. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 12 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 3 ancestors has a recall of any class.
- 4 other devices also cite its predicate K050742.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2013, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, not matched to any one device; reports are not rates.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
What is it indicated for?
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.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K122146 · printed Nov 5, 2026
Cite this page
510(k) Report. “K122146: Xhibit Central Station, Model 96102.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K122146
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026