510(k) · Cleared

Recalled · 2009

Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software

K090556510(k) TraditionalCleared Apr 30, 200959-day reviewClass II21 CFR 870.1025Recalls 1

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Spacelabs Healthcare Medical Equipment (Suzhou) CO · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on Apr 30, 2009 as substantially equivalent to K001775 (Zoe Medical, Inc., 2001) and 4 other predicates after a 59-day review. Its family tree reaches back 9 generations to 1997. 1 of the 81 devices in its family, counting itself, has a Class I recall. 10 later devices descend from it. It has been recalled once.

Decided: Apr 30, 2009
Review: 59 days
Class: Class II
Product code: MHX
Recalls: 1
Predicates: 5

Its longest line of descent runs back 9 generations to K962603 (1997). 70 ancestors in all, the oldest K842616 (1984). 10 later devices descend from it, 4 citing it directly. 1 of the 81 devices in this family, counting this one, has a Class I recall.

By dateBy generation

Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
5 generations between
3 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
2 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
1 generation backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
This deviceK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009
Descendant · cites it directly · 3 of its ownK130740 Nightingale Monitoring SystemZoe Medical, Inc. · 2013
Descendant · cites it directly · 2 of its ownK123556 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · Recalled
Descendant · 2 generations on · 1 of its ownK161517 Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017
Descendant · 2 generations on · 1 of its ownK152043 Diagnostic Station DS20Schiller AG · 2016
Descendant · cites it directly · 1 of its ownK093501 Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc. · 2009 · Recalled

Show all 9 generations

Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
5 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
4 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
3 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
2 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
1 generation backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
This deviceK090556 Spacelabs Elance Vital Signs Monitoring System and Central Monitor…Spacelabs Healthcare Medical Equipment (Suzhou) CO · 2009

Showing 5 of 10 descendants. See all descendants

Descendants cleared per year

2009high 2 (2013) · low 0 (2011)2026

Class I recalls in this family

K970209 Capnocheck Plus4 generations back · 1997

Most influential descendants

Showing 5 of 10 · See all

K130740Nightingale Monitoring SystemZoe Medical, Inc. · 2013 · cites it directly3descendants
K123556Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2013 · cites it directly2descendants
K161517Mortara Surveyor Patient MonitorMortara Instrument, Inc. · 2017 · 2 generations on1descendant
K152043Diagnostic Station DS20Schiller AG · 2016 · 2 generations on1descendant
K093501Elance Vital Signs Monitor and Elance Central StationSpacelabs Medical, Inc. · 2009 · cites it directly1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−9	K962603	Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables	Masimo Corp.	1997	—
−8	K973887	Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables	Masimo Corp.	1998	—
−7	K982255	Model 2000 Pulse Oximeter	Ivy Biomedical Systems, Inc.	1998	—
−6	K991823	N-395 Pulse Oximeter, Model N-395	Nellcor Puritan Bennett, Inc.	1999	—
−5	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and…	Nellcor Puritan Bennett, Inc.	2002	1
−4	K021090	Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter	Nellcor Puritan Bennett, Inc.	2002	—
−3	K033048	Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL…	Cas Medical Systems, Inc.	2004	1
−2	K050844	750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL…	Cas Medical Systems, Inc.	2005	—
−1	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter…	Oridion Capnography, Inc.	2006	3
0 (this device)	K090556	Spacelabs Elance Vital Signs Monitoring System and Central Monitor Software	Spacelabs Healthcare Medical Equipment (Suzhou) CO	2009	—
+1	K130740	Nightingale Monitoring System	Zoe Medical, Inc.	2013	—
+1	K123556	Mortara Surveyor Patient Monitor	Mortara Instrument, Inc.	2013	1
+2	K161517	Mortara Surveyor Patient Monitor	Mortara Instrument, Inc.	2017	—
+2	K152043	Diagnostic Station DS20	Schiller AG	2016	—
+1	K093501	Elance Vital Signs Monitor and Elance Central Station	Spacelabs Medical, Inc.	2009	2

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

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2009	1	0
2010	1	0
2013	2	0
2015	2	0
2016	1	0
2017	2	0
2018	1	0

FIG. 1 — Lineage of K090556, 1997–2018Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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

Get a 510(k) Report

What was it cleared against? (5)

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	Applicant	Decided	Recalls
*	K001775	Zoe Medical Nightingale Monitoring System Summary page 2 …510(k) Predicate EquivalentDevices: Monitoring System Number Manufacturer/ Model ECG component K001775 Zoe Medical Nightingale Respiration component Monitoring System…	Zoe Medical, Inc.	2001	—
*	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor Summary page 2 …Invasive blood pressures component Temperature component Expired and/or inspired CO 2 K060065 Oridion Capnostream 20 component Functional arterial oxygen K033296…	Oridion Capnography, Inc.	2006	3
*	K033296	Masimo Set Rad-5 Pulse Oximeter, Model Rad-5; Masimo Set Rad-5V Pulse Oximeter, Model… Summary page 2 …Expired and/or inspired CO 2 K060065 Oridion Capnostream 20 component Functional arterial oxygen K033296 Masimo Corporation SET saturation component Rad 5 MS-I1 board…	Masimo Corp.	2004	1
*	K062144	Escort M8 Vital Signs Patient Monitor, Model 3810 Summary page 2 …simo Corporation SET saturation component Rad 5 MS-I1 board Arrhythmia detection and K062144 Invivo Escort M8 Vital invasive pressure monitoring Signs Patient Monitor…	Invivo Corporation	2006	—
*	K012891	Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and Cables… Summary page 2 …Signs Patient Monitor (IBP) Model 3810 Functional arterial oxygen K012891 Nellcor Oximax N-595 saturation component pulse oximeter Device…	Nellcor Puritan Bennett, Inc.	2002	1

Also cleared against K001775: 2 other devices →

What descends from it? (10)

4 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K130740	Nightingale Monitoring System	Zoe Medical, Inc.	2013	3
K123556	Mortara Surveyor Patient Monitor	Mortara Instrument, Inc.	2013	2
K093501	Elance Vital Signs Monitor and Elance Central Station	Spacelabs Medical, Inc.	2009	1
K093802	Ultraview DM3 Monitor	Zoe Medical, Inc.	2010	0

Has anything in its family been recalled? (1 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jul 23, 2009	Not classified	Z-2211-2009	Process control	The Spacelabs Medical Integrated ECG Cables, PN: 700-0008-22, 700-0008-23, 700-0008-24, and 700-0008-25 will not withstand the high voltage of a defibrillation shock.

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 · 4 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall

What does this lineage say?

The line of descent spans 12 years and passes through 6 companies; a new generation was cleared every 11 months on median.
15 of the 70 ancestors have a recall of any class; 1 has a Class I recall.
Of its descendants, K130740 (Zoe Medical, Inc., 2013) has gone furthest, with 3 descendants of its own.
2 other devices also cite its predicate K001775.

How does its category compare?

All MHX devices

MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007high 248 (2014) · low 57 (2009)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · MHX

21so far in 2026, the most since 2007

2007high 21 (2026) · low 0 (2020)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · MHX

3,761in 2025

2007high 3,761 (2025) · low 131 (2007)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 elance Vital Signs Monitor is indicated for use in patient populations for:

- Adult

- Pediatric

The Spacelabs elance Vital Signs Monitor facilitates the monitoring of:

- ECG with arrhythmia detection

- Respiration

- Non-invasive blood pressures

- Invasive blood pressures

- Body temperature

- Functional arterial oxygen saturation, and

- End title CO2 •

The Spacelabs elance Vital Signs Monitor 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/K090556 · printed Nov 6, 2026

Cite this page

510(k) Report. “K090556: Spacelabs Elance Vital Signs Monitoring System and 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/K090556

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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