510(k) · Cleared
Clearedelance Vital Signs Monitor, Central Monitor Software
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 Nov 5, 2015 as substantially equivalent to K093501 (Spacelabs Medical, Inc., 2009) and 2 other predicates after a 268-day review. Its family tree reaches back 11 generations to 1997. 1 of the 73 devices in its family, counting itself, has a Class I recall.
- Decided
- Nov 5, 2015
- Review
- 268 days
- Class
- Class II
- Product code
- MHX
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 11 generations to K962603 (1997). 72 ancestors in all, the oldest K842616 (1984). No later device cites it as a predicate yet. 1 of the 73 devices in this family, counting this one, has a Class I recall.
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 7 generations between
- 3 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 2 generations backK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · Recalled
- 1 generation backK093501 Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc. · 2009 · Recalled
- This deviceK150329 elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare · 2015
Show all 11 generations
- Root · 11 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 10 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 9 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 8 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 7 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 6 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 5 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 4 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 3 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 2 generations backK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009 · Recalled
- 1 generation backK093501 Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc. · 2009 · Recalled
- This deviceK150329 elance Vital Signs Monitor, Central Monitor SoftwareSpacelabs Healthcare · 2015
Class I recalls in this family
- K970209 Capnocheck Plus6 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −11 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −10 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −9 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −8 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −7 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −6 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −5 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −4 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −3 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −2 | K090556 | Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software | Spacelabs Healthcare Medical Equipment (Suzhou) CO | 2009 | 1 |
| −1 | K093501 | Elance Vital Signs Monitor and Elance Central Station | Spacelabs Medical, Inc. | 2009 | 2 |
| 0 (this device) | K150329 | elance Vital Signs Monitor, Central Monitor Software | Spacelabs Healthcare | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1984 | 1 | 0 |
| 1989 | 1 | 0 |
| 1990 | 4 | 0 |
| 1991 | 4 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 5 | 0 |
| 1995 | 7 | 0 |
| 1996 | 5 | 0 |
| 1997 | 6 | 1 |
| 1998 | 6 | 0 |
| 1999 | 5 | 0 |
| 2000 | 3 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 2 | 0 |
| 2004 | 2 | 0 |
| 2005 | 1 | 0 |
| 2006 | 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.
1 device in this family has a Class I recall. 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? (3)
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 |
|---|---|---|---|
| * | K093501 | Elance Vital Signs Monitor and Elance Central StationSummary page 4…dicate Predicate Equivalent Devices: 510(k) Number Manufacturer / Model Spacelabs Healthcare élance K093501 Spacelabs Healthcare élance Vital Signs Monitor and Vital Signs Monitor an… | 2009 |
| * | K033296 | Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model…Summary page 4…l Signs Monitor and élance élance Central Station Central Station K033296 Masimo Corporation Masimo SET® Rad-5 Pulse Oximete… | 2004 |
| * | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables…Summary page 4…rporation Masimo SET® Rad-5 Pulse Oximeter K012891 Nellcor Puritan Bennett Incorporated OxiMAX Pulse… | 2002 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
Relatives with a Class I recall
Class I is FDA’s most serious recall class. A recall in the family tree is context for this device, not evidence about it.
- K970209Capnocheck PlusBci Intl., Inc. · 1997 · 6 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 18 years and passes through 8 companies; a new generation was cleared every 11 months on median.
- 17 of the 72 ancestors have a recall of any class; 1 has a Class I recall.
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. 2015, 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 élance Vital Signs Monitor and élance Central Station is indicated for use in patient populations for:
- Adult
- Pediatric (1 year old and above)
The Spacelabs élance Vital Signs Monitor and élance Central Station facilitates the monitoring of:
- ECG with arrhythmia detection
- Respiration
- Non-invasive blood pressures
- Invasive blood pressures
- Body temperature
- Functional arterial oxygen saturation, and
- End tidal CO2.
The Spacelabs élance Vital Signs Monitor and élance Central Station is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K150329 · printed Nov 6, 2026
Cite this page
510(k) Report. “K150329: elance Vital Signs Monitor, Central Monitor Software.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K150329
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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