510(k) · Cleared

Recalled · 2011

Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068

K101067510(k) SpecialCleared May 7, 201021-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

Philips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)

Cleared on May 7, 2010 as substantially equivalent to K052707 (Philips Medical Systems, 2005) and 2 other predicates after a 21-day review. Its family tree reaches back 7 generations to 1994. 7 later devices descend from it. It has been recalled once.

Decided: May 7, 2010
Review: 21 days
Class: Class II
Product code: MHX
Recalls: 1
Predicates: 3

Its longest line of descent runs back 7 generations to K941811 (1994). 25 ancestors in all, the oldest K903523 (1990). 7 later devices descend from it, 2 citing it directly.

By dateBy generation

Root · 7 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
6 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
5 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
4 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
3 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
2 generations backK052707 M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 2005 · Recalled
1 generation backK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · Recalled
This deviceK101067 Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064…Philips Medical Systems · 2010
Descendant · cites it directly · 6 of its ownK103652 Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6…Philips Medical Systesms · 2011
Descendant · cites it directly · 5 of its ownK123900 Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 2013 · Recalled
Descendant · 2 generations on · 3 of its ownK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
Descendant · 3 generations on · 2 of its ownK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
Descendant · 4 generations on · 1 of its ownK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · Recalled

Showing 5 of 7 descendants. See all descendants

Descendants cleared per year

2011high 1 (2011) · low 0 (2012)2026

Most influential descendants

Showing 5 of 7 · See all

K103652Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8Philips Medical Systesms · 2011 · cites it directly6descendants
K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 2013 · cites it directly5descendants
K133961Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014 · 2 generations on3descendants
K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015 · 3 generations on2descendants
K163649SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · 4 generations on1descendant

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−7	K941811	HP M1175A, M1176A, Component Monitoring System	Hewlett-Packard Co.	1994	—
−6	K960934	HP M1205A Omnicare Component Monitor System Model 24	Hewlett-Packard Co.	1996	—
−5	K981376	Hewlett-Packard M1205A Viridia 24 CT	Hewlett-Packard Co.	1999	—
−4	K990125	HP Viridia Component Monitoring System, Model Rev. K	Hewlett-Packard GmbH	1999	—
−3	K990972	HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…	Hewlett-Packard GmbH	1999	—
−2	K052707	M3046B Compact Portable Patient Monitors	Philips Medical Systems	2005	1
−1	K080495	Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3	Philips Medical Systems	2008	1
0 (this device)	K101067	Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065…	Philips Medical Systems	2010	—
+1	K103652	Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and…	Philips Medical Systesms	2011	—
+1	K123900	Suresigns VM4, Suresigns VM6, Suresigns VM8	Philips Medical Systems	2013	2
+2	K133961	Suresigns VS3, Suresigns VS4	Philips Medical Systems	2014	—
+3	K151761	SureSigns VS3, SureSigns VS4	Phillips Medical Systems	2015	—
+4	K163649	SureSigns VS3; SureSigns VS4	Philips Medical Systems	2017	10

Other ancestors by year cleared

Year cleared	Devices	With a Class I recall
1990	1	0
1992	1	0
1993	1	0
1994	1	0
1995	1	0
1996	1	0
1997	2	0
1998	2	0
1999	1	0
2000	6	0
2009	1	0

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2011	1	0
2013	1	0
2014	1	0
2015	1	0
2016	1	0
2017	1	0
2019	1	0

FIG. 1 — Lineage of K101067, 1994–2019Source: 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.

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

Get a 510(k) 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	Applicant	Decided	Recalls
*	K052707	M3046B Compact Portable Patient Monitors Summary page 2 …0 6. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707, K080495 and K090483. 7. The modifications are as follows: * The OEM CO2 module, from Oridion Medical Ltd. isbeing changed t…	Philips Medical Systems	2005	1
*	K080495	Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 Summary page 2 …ge 2 === 6. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707, K080495 and K090483. 7. The modifications are as follows: * The OEM CO2 module, from Oridion Medical Ltd. isbeing changed to a new v…	Philips Medical Systems	2008	1
*	K090483	Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series… Summary page 2 …modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707, K080495 and K090483. 7. The modifications are as follows: * The OEM CO2 module, from Oridion Medical Ltd. isbeing changed to a new version of the…	Philips Medical Systems	2009	5
†	K060065	CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter Bedside Monitor	Oridion Capnography, Inc.	2006	3
†	K082280	Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital…	Philips Medical Systems North America Co.	2008	—

Also cleared against K052707: 6 other devices →

What descends from it? (7)

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

Number	Device	Applicant	Decided	Descendants
K103652	Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8	Philips Medical Systesms	2011	6
K123900	Suresigns VM4, Suresigns VM6, Suresigns VM8	Philips Medical Systems	2013	5

Has anything in its family been recalled? (0 Class I)

Recalls of this device

Date	Class	Recall	Root cause	Reason
Jun 10, 2011	Not classified	Z-2583-2011	Device Design	Speakers on the SureSigns Patient Monitors and Vital Signs, failure may be identified by the display of a Speaker Malfunc message in the alarm message area or an AUDIO FAILED message in the main screen of the device or by the absence of…

No ancestor or descendant has a Class I recall.

What does this lineage say?

The line of descent spans 16 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
4 of the 25 ancestors have a recall of any class.
Of its descendants, K103652 (Philips Medical Systesms, 2011) has gone furthest, with 6 descendants of its own.
6 other devices also cite its predicate K052707.

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. 2010, 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?

Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K101067 · printed Nov 5, 2026

Cite this page

510(k) Report. “K101067: Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K101067

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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