510(k) · Cleared
Recalled · Class II · 2025Spacelabs Healthcare Xprezzon Beside Monitor (9913930)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Spacelabs Medical, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Nov 2, 2011 as substantially equivalent to K102422 (Spacelabs Medical, Inc., 2010) after a 28-day review. Its family tree reaches back 3 generations to 1984. It has been recalled 7 times.
- Decided
- Nov 2, 2011
- Review
- 28 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 7
- Predicates
- 1
Its longest line of descent runs back 3 generations to K842616 (1984). 4 ancestors in all. No later device cites it as a predicate yet.
- Root · 3 generations backK842616 Spacelabs Alpha PC Patient ComputerSpacelabs, Inc. · 1984 · Recalled
- 2 generations backK972282 Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc. · 1997 · Recalled
- 1 generation backK102422 Spacelabs Medical Patient MonitorsSpacelabs Medical, Inc. · 2010 · Recalled
- This deviceK112962 Spacelabs Healthcare Xprezzon Beside Monitor (9913930)Spacelabs Medical, Inc. · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K842616 | Spacelabs Alpha PC Patient Computer | Spacelabs, Inc. | 1984 | 2 |
| −2 | K972282 | Spacelabs Medical Pcis Patient Monitors | Spacelabs Medical, Inc. | 1997 | 4 |
| −1 | K102422 | Spacelabs Medical Patient Monitors | Spacelabs Medical, Inc. | 2010 | 3 |
| 0 (this device) | K112962 | Spacelabs Healthcare Xprezzon Beside Monitor (9913930) | Spacelabs Medical, Inc. | 2011 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
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 |
|---|---|---|---|
| * | K102422 | Spacelabs Medical Patient MonitorsSummary page 1…K03142. Predicate Device: Device Name: Spacelabs Medical Patient Monitors 51 0(k) Number: K1 02422 Manufacturer: Spacelabs Medical, Inc.… | 2010 |
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 |
|---|---|---|---|---|
| Sep 5, 2025 | Class II | Z-0169-2026 | Device Design | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically… |
| Sep 5, 2025 | Class II | Z-0167-2026 | Device Design | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically… |
| Sep 5, 2025 | Class II | Z-0168-2026 | Device Design | Due to display cables used for monitors were not in compliance with electromagnetic interference from inadequately shielded cables which may pose serious risk to patient's safety by interfering with the operation of another electronically… |
| Jan 28, 2015 | Class II | Z-1144-2015 | Device Design | Spacelabs Healthcare XPREZZON Bedside Monitors, Model 91393, are recalled because the firm has received multiple reports of XPREZZON monitors failing to boot up or returning to factory default configuration settings following power on or… |
| Oct 5, 2012 | Class II | Z-0196-2013 | Vendor change control | Potential failure of Spacelabs Healthcare Touchscreen Display, Model 94267 where the alarm lights failed to illuminate upon installation. |
| Jun 12, 2012 | Class II | Z-2019-2012 | Software design | There were reports that a certain combination of key presses will cause the module to disconnect from the Xprezzon bedside monitor, model 91393, and the patient parameters will drop from the display. The parameters return after power… |
| May 22, 2012 | Not classified | Z-1705-2012 | Device Design | The screw used to connect the external power supply to the Spacelabs Medical Xprezzon Bedside Monitor, Model 91393, may damage an internal capacitor. The damage may result in an inability of the monitor to power on, power off, or… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 27 years and passes through 2 companies; a new generation was cleared every 12.9 years on median.
- 3 of the 4 ancestors have a recall of any class.
- 2 other devices also cite its predicate K102422.
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. 2011, 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 Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLC based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional…
Read the full statement (229 words)
The Spacelabs Healthcare Xprezzon Bedside Monitor passively displays data generated by Spacelabs parameter modules, Flexport interfaces, and other Spacelabs SDLC based products as waveform and numeric displays, trends and alarms. Key monitored parameters available on the model 91393, when employing the Spacelabs Command Module, consist of ECG, respiration, invasive and noninvasive blood pressure, SpO2, temperature and cardiac output. Additional parameters and interfaces to other systems are also available depending on the parameter modules employed.
The Spacelabs Healthcare Xprezzon Bedside Monitor is intended to alra the user to alarm conditions that are reported by Spacelabs Healthcare parameter modules and/or other devices via Flexport interfaces. The patient monitors are also capable of displaying alarm conditions on other monitors that are on the network through the Alarm Watch feature.
The Spacelabs Healthcare Xprezzon Bedside Monitor may also function as a generic display or computer terminal. As a generic display or terminal, the patient monitor allows network based applications to open windows and display information the Xprezzon and other networked monitors.
The Spacelabs Healthcare Xprezzon Bedside Monitor is 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.
The Xprezzon Bedside Monitors is 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.
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/K112962 · printed Nov 6, 2026
Cite this page
510(k) Report. “K112962: Spacelabs Healthcare Xprezzon Beside Monitor (9913930).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K112962
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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