510(k) · Cleared
Recalled · Class II · 2014Spacelabs Medical Patient Monitors
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 Dec 7, 2010 as substantially equivalent to K972282 (Spacelabs Medical, Inc., 1997) after a 104-day review. Its family tree reaches back 2 generations to 1984. 3 later devices descend from it. It has been recalled 3 times.
- Decided
- Dec 7, 2010
- Review
- 104 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 3
- Predicates
- 1
Its longest line of descent runs back 2 generations to K842616 (1984). 3 ancestors in all. 3 later devices descend from it, 3 citing it directly.
- Root · 2 generations backK842616 Spacelabs Alpha PC Patient ComputerSpacelabs, Inc. · 1984 · Recalled
- 1 generation backK972282 Spacelabs Medical Pcis Patient MonitorsSpacelabs Medical, Inc. · 1997 · Recalled
- This deviceK102422 Spacelabs Medical Patient MonitorsSpacelabs Medical, Inc. · 2010
- Descendant · cites it directly · 0 of its ownK160667 Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK120616 Spacelabs Healthcare Qube Compact Monitor (91390Spacelabs Medical, Inc. · 2012 · Recalled
- Descendant · cites it directly · 0 of its ownK112962 Spacelabs Healthcare Xprezzon Beside Monitor (9913930)Spacelabs Medical, Inc. · 2011 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K160667Anybattery C2 Rechargeable BatteryAnybattery, Inc. · 2017 · cites it directly0descendants
- K120616Spacelabs Healthcare Qube Compact Monitor (91390Spacelabs Medical, Inc. · 2012 · cites it directly0descendants
- K112962Spacelabs Healthcare Xprezzon Beside Monitor (9913930)Spacelabs Medical, Inc. · 2011 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K842616 | Spacelabs Alpha PC Patient Computer | Spacelabs, Inc. | 1984 | 2 |
| −1 | K972282 | Spacelabs Medical Pcis Patient Monitors | Spacelabs Medical, Inc. | 1997 | 4 |
| 0 (this device) | K102422 | Spacelabs Medical Patient Monitors | Spacelabs Medical, Inc. | 2010 | — |
| +1 | K160667 | Anybattery C2 Rechargeable Battery | Anybattery, Inc. | 2017 | — |
| +1 | K120616 | Spacelabs Healthcare Qube Compact Monitor (91390 | Spacelabs Medical, Inc. | 2012 | 9 |
| +1 | K112962 | Spacelabs Healthcare Xprezzon Beside Monitor (9913930) | Spacelabs Medical, Inc. | 2011 | 7 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1993 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2017 | 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 |
|---|---|---|---|
| * | K972282 | Spacelabs Medical Pcis Patient MonitorsSummary page 1…The model 91496 was cleared under K050605. Predicate Device Name: Spacelabs Medical PCIS Patient Monitors Devices 510(k) Number: K972282 Manufacturer: Spacelabs Medical Inc. Spacelabs Medical 510(k)… | 1997 |
What descends from it? (3)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 26, 2014 | Class II | Z-2707-2014 | Environmental control | 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 since 2011 and discovered 222 additional… |
| Jul 8, 2011 | Not classified | Z-3032-2011 | Device Design | 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 | Other | 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 customers may lose any changes they… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 26 years and passes through 2 companies; a new generation was cleared every 13.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K160667 (Anybattery, Inc., 2017) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K972282.
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. 2010, 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?
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…
Read the full statement (267 words)
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102422 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102422: Spacelabs Medical Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102422
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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