510(k) Report

510(k) · Cleared

Cleared

Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8

K103652510(k) SpecialCleared Jan 13, 201130-day reviewClass II21 CFR 870.1025

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

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

Cleared on Jan 13, 2011 as substantially equivalent to K052707 (Philips Medical Systems, 2005) and 3 other predicates after a 30-day review. Its family tree reaches back 8 generations to 1994. 6 later devices descend from it.

Decided
Jan 13, 2011
Review
30 days
Class
Class II
Product code
MHX
Recalls
None
Predicates
4

Its longest line of descent runs back 8 generations to K941811 (1994). 26 ancestors in all, the oldest K903523 (1990). 6 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2009: 1 other ancestor2000: 6 other ancestors1999: 1 other ancestor1998: 2 other ancestors1997: 2 other ancestors1993: 1 other ancestor1990: 1 other ancestor1996: 1 other ancestor1995: 1 other ancestor1994: 1 other ancestor1992: 1 other ancestor2013: 1 descendant cleared2014: 1 descendant cleared2016: 1 descendant cleared2015: 1 descendant cleared2019: 1 descendant cleared2017: 1 descendant clearedK941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996×3: 3 generations cleared close together, K981376 (1999), K990125 (1999), K990972 (1999) K052707 · M3046B Compact Portable Patient Monitors · Philips Medical Systems · 2005 · recalledK080495 · Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 · Philips Medical Systems · 2008 · recalledK101067 · Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068 · Philips Medical Systems · 2010 · recalled1990200020102020
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor2 generations back: 9 other ancestors3 generations back: 3 other ancestors4 generations back: 1 other ancestor5 generations back: 4 other ancestors 1 generation forward: 1 descendant2 generations forward: 2 descendants3 generations forward: 2 descendants4 generations forward: 1 descendant K101067 · Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068 · Philips Medical Systems · 2010 · recalledK080495 · Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 · Philips Medical Systems · 2008 · recalledK052707 · M3046B Compact Portable Patient Monitors · Philips Medical Systems · 2005 · recalledK990972 · HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia Multi-Measurement Server and Compact Portable T · Hewlett-Packard GmbH · 1999K990125 · HP Viridia Component Monitoring System, Model Rev. K · Hewlett-Packard GmbH · 1999K981376 · Hewlett-Packard M1205A Viridia 24 CT · Hewlett-Packard Co. · 1999K960934 · HP M1205A Omnicare Component Monitor System Model 24 · Hewlett-Packard Co. · 1996K941811 · HP M1175A, M1176A, Component Monitoring System · Hewlett-Packard Co. · 1994−50
  1. Root · 8 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
  2. 7 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
  3. 6 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
  4. 5 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
  5. 4 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
  6. 3 generations backK052707 M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 2005 · Recalled
  7. 2 generations backK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · Recalled
  8. 1 generation backK101067 Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064…Philips Medical Systems · 2010 · Recalled
  9. This deviceK103652 Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6…Philips Medical Systesms · 2011
  10. Descendant · cites it directly · 5 of its ownK123900 Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 2013 · Recalled
  11. Descendant · 2 generations on · 3 of its ownK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
  12. Descendant · 3 generations on · 2 of its ownK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
  13. Descendant · 4 generations on · 1 of its ownK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · Recalled
  14. Descendant · 3 generations on · 0 of its ownK190624 EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019 · Recalled

Showing 5 of 6 descendants. See all descendants

Descendants cleared per year

2013: 12014: 12015: 12016: 12017: 12019: 1
2013high 1 (2013) · low 0 (2018)2026

Most influential descendants

Showing 5 of 6 · See all
  • 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
  • K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019 · 3 generations on0descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−8K941811HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co.1994—
−7K960934HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co.1996—
−6K981376Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co.1999—
−5K990125HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH1999—
−4K990972HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Hewlett-Packard GmbH1999—
−3K052707M3046B Compact Portable Patient MonitorsPhilips Medical Systems20051
−2K080495Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems20081
−1K101067Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065…Philips Medical Systems20101
0 (this device)K103652Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and…Philips Medical Systesms2011—
+1K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems20132
+2K133961Suresigns VS3, Suresigns VS4Philips Medical Systems2014—
+3K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems2015—
+4K163649SureSigns VS3; SureSigns VS4Philips Medical Systems201710
+3K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH20193

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
199010
199210
199310
199410
199510
199610
199720
199820
199910
200060
200910

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201310
201410
201510
201610
201710
201910
FIG. 1 — Lineage of K103652, 1994–2019Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) Report

What was it cleared against? (4)

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.

TypeNumberDeviceApplicantDecidedRecalls
*K052707M3046B Compact Portable Patient Monitors
Summary page 2
…Ko3/.5 6. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707. K080495. K090483, and K1 01067. 7. The modifications are as follows: * The alarm limit range for the Heart Rate (HR) so…
Philips Medical Systems20051
*K080495Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3
Summary page 2
…Ko3/.5 6. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707. K080495. K090483, and K1 01067. 7. The modifications are as follows: * The alarm limit range for the Heart Rate (HR) sourced fro…
Philips Medical Systems20081
*K090483Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series…
Summary page 2
…6. The modified devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707. K080495. K090483, and K1 01067. 7. The modifications are as follows: * The alarm limit range for the Heart Rate (HR) sourced from the EGG…
Philips Medical Systems20095
*K101067Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068
Summary page 2
…devices are substantially equivalent to previously cleared Philips device, SureSigns VM Series Patient Monitors marketed pursuant to K052707. K080495. K090483, and K1 01067. 7. The modifications are as follows: * The alarm limit range for the Heart Rate (HR) sourced from the EGG, the SPO2, or th…
Philips Medical Systems20101

Also cleared against K052707: 6 other devices →

What descends from it? (6)

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems20135

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

No FDA recall names this device.

No ancestor or descendant has a Class I recall.

What does this lineage say?

  • The line of descent spans 17 years and passes through 4 companies; a new generation was cleared every 2.1 years on median.
  • 5 of the 26 ancestors have a recall of any class.
  • Of its descendants, K123900 (Philips Medical Systems, 2013) has gone furthest, with 5 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. 2011, this device’s year, is highlighted.

FDA decisions per year · MHX

8in 2025

2007: 152008: 162009: 132010: 202011: 122012: 162013: 212014: 132015: 142016: 132017: 142018: 112019: 72020: 112021: 52022: 152023: 82024: 52025: 82026 (partial year): 14
2007high 21 (2013) · low 5 (2021)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · MHX

192in 2025

2007: 96 days median2008: 58 days median2009: 57 days median2010: 90 days median2011: 81 days median2012: 88 days median2013: 120 days median2014: 248 days median2015: 203 days median2016: 149 days median2017: 134 days median2018: 203 days median2019: 243 days median2020: 196 days median2021: 195 days median2022: 189 days median2023: 229 days median2024: 181 days median2025: 192 days median2026 (partial year): 205 days median
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

2007: 32008: 22009: 72010: 132011: 162012: 112013: 142014: 62015: 52016: 72017: 62018: 122019: 62022: 62023: 32024: 32025: 152026 (partial year): 21
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

2007: 1312008: 2322009: 3822010: 9552011: 9492012: 6762013: 1,9972014: 1,6092015: 1,2842016: 1,1052017: 1,1152018: 2,1572019: 1,4622020: 1,7142021: 2,4232022: 1,4702023: 2,2542024: 2,8142025: 3,761
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
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
200715963131
200816582232
200913577382
2010209013955
2011128116949
2012168811676
201321120141,997
20141324861,609
20151420351,284
20161314971,105
20171413461,115
201811203122,157
2019724361,462
20201119601,714
2021519502,423
20221518961,470
2023822932,254
2024518132,814
20258192153,761
20261420521—

What is it indicated for?

Indicated for use by health care professionals whenever there is a need for

monitoring the physiological parameters of patients.

Standard and optional parameters include:

*ECG

-Respiration

*NBP

*Sp02

*IBP

*C02

*Temperature

Indications for use as stated in the FDA summary.

Also cleared against K052707

6 other devices cite the same predicate.

  • K131913Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T, MP5SCPhilips Medizin Systeme Boeblingen GmbH · 20131 recall
  • K123900Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 20132 recalls
  • K101067Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068Philips Medical Systems · 20101 recall
  • K090483Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series Patient MonitorsPhilips Medical Systems · 20095 recalls
  • K082280Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital Signs MonitorPhilips Medical Systems North America Co. · 2008
  • K080495Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 20081 recall

Recent decisions in MHX

The MHX category page

  • K260676Radius VSM and AccessoriesMasimo Corporation · 2026
  • K260656Carescape ONE; Carescape Dock F0; TruSignal ECG MM; TruSignal PRES MM; TruSignal TEMP MM; TruSignal SpO2 MM…GE Healthcare Finland Oy · 2026
  • K260343Carescape Canvas 1000; Carescape Canvas Smart DisplayGE Healthcare Finland Oy · 2026
  • K260579Infinity® Acute Care System (IACS) – VG8.1Draeger Medical Systems, Inc. · 2026
  • K251508Telemetry Monitor (iT30, iT50)Edan Instruments, Inc. · 2026

https://510kreport.com/device/K103652 · printed Nov 5, 2026

Cite this page

510(k) Report. “K103652: Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K103652

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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