510(k) · Cleared
Recalled · Class II · 2021Suresigns VM4, Suresigns VM6, Suresigns VM8
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Apr 18, 2013 as substantially equivalent to K052707 (Philips Medical Systems, 2005) and 5 other predicates after a 121-day review. Its family tree reaches back 12 generations to 1997. 1 of the 71 devices in its family, counting itself, has a Class I recall. 5 later devices descend from it. It has been recalled 2 times.
- Decided
- Apr 18, 2013
- Review
- 121 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 2
- Predicates
- 6
Its longest line of descent runs back 12 generations to K962603 (1997). 65 ancestors in all, the oldest K893221 (1990). 5 later devices descend from it, 2 citing it directly. 1 of the 71 devices in this family, counting this one, has a Class I recall.
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations between
- 3 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 2 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 1 generation backK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
- This deviceK123900 Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 2013
- Descendant · cites it directly · 3 of its ownK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
- Descendant · 2 generations on · 2 of its ownK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
- Descendant · 3 generations on · 1 of its ownK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · Recalled
- Descendant · 2 generations on · 0 of its ownK190624 EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019 · Recalled
- Descendant · cites it directly · 0 of its ownK151812 Patient Monitors Various ModelsPhilips Medical Systems · 2016
Show all 12 generations
- Root · 12 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 10 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 9 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 8 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 7 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 6 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 5 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 4 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 3 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 2 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 1 generation backK094012 CAPNOSTREAM20 with MICROMEDICO2 ModuleOridion Capnography, Inc. · 2010
- This deviceK123900 Suresigns VM4, Suresigns VM6, Suresigns VM8Philips Medical Systems · 2013
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
Most influential descendants
Showing 5 of 5 · See all- K133961Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014 · cites it directly3descendants
- K151761SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015 · 2 generations on2descendants
- K163649SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · 3 generations on1descendant
- K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019 · 2 generations on0descendants
- K151812Patient Monitors Various ModelsPhilips Medical Systems · 2016 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −12 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −11 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −10 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −9 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −8 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −7 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −6 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −5 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −4 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −3 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −2 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −1 | K094012 | CAPNOSTREAM20 with MICROMEDICO2 Module | Oridion Capnography, Inc. | 2010 | — |
| 0 (this device) | K123900 | Suresigns VM4, Suresigns VM6, Suresigns VM8 | Philips Medical Systems | 2013 | — |
| +1 | K133961 | Suresigns VS3, Suresigns VS4 | Philips Medical Systems | 2014 | — |
| +2 | K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015 | — |
| +3 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 10 |
| +2 | K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019 | 3 |
| +1 | K151812 | Patient Monitors Various Models | Philips Medical Systems | 2016 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 3 | 0 |
| 1991 | 2 | 0 |
| 1992 | 2 | 0 |
| 1993 | 2 | 0 |
| 1994 | 2 | 0 |
| 1995 | 5 | 0 |
| 1996 | 4 | 0 |
| 1997 | 4 | 1 |
| 1998 | 6 | 0 |
| 1999 | 7 | 0 |
| 2000 | 7 | 0 |
| 2002 | 1 | 0 |
| 2003 | 1 | 0 |
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 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? (6)
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 |
|---|---|---|---|
| * | K052707 | M3046B Compact Portable Patient MonitorsSummary page 1…______ 6. The modified devices are substantially equivalent to previously cleared PhIlipsadevice, SureSigns VM4, VM6 and VMS Patient Monitors marketed pursuant to K052707, K080495, K090483, and K101067. The predicate 51lOKs for this submission are: K<103652 and K094012 (May 12 2010) by Oridion… | 2005 |
| * | K080495 | Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Summary page 1…6. The modified devices are substantially equivalent to previously cleared PhIlipsadevice, SureSigns VM4, VM6 and VMS Patient Monitors marketed pursuant to K052707, K080495, K090483, and K101067. The predicate 51lOKs for this submission are: K<103652 and K094012 (May 12 2010) by Oridion Capnogra… | 2008 |
| * | K090483 | Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series…Summary page 1…ified devices are substantially equivalent to previously cleared PhIlipsadevice, SureSigns VM4, VM6 and VMS Patient Monitors marketed pursuant to K052707, K080495, K090483, and K101067. The predicate 51lOKs for this submission are: K<103652 and K094012 (May 12 2010) by Oridion Capnography Inc.… | 2009 |
| * | K101067 | Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068Summary page 1…are substantially equivalent to previously cleared PhIlipsadevice, SureSigns VM4, VM6 and VMS Patient Monitors marketed pursuant to K052707, K080495, K090483, and K101067. The predicate 51lOKs for this submission are: K<103652 and K094012 (May 12 2010) by Oridion Capnography Inc.… | 2010 |
| * | K103652 | Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8Summary page 1…psadevice, SureSigns VM4, VM6 and VMS Patient Monitors marketed pursuant to K052707, K080495, K090483, and K101067. The predicate 51lOKs for this submission are: K<103652 and K094012 (May 12 2010) by Oridion Capnography Inc.… | 2011 |
| * | K094012 | CAPNOSTREAM20 with MICROMEDICO2 ModuleSummary page 1…SureSigns VM4, VM6 and VMS Patient Monitors marketed pursuant to K052707, K080495, K090483, and K101067. The predicate 51lOKs for this submission are: K<103652 and K094012 (May 12 2010) by Oridion Capnography Inc.… | 2010 |
What descends from it? (5)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 23, 2021 | Class II | Z-1326-2021 | Software design | Fail to Comply with Chinese Standard YY1079-2008: Clauses 4.2.6 and 4.2.7.3. Range/accuracy of heart rate meter for pediatric mode-In pediatric mode, when the input signal rate is over 300 bpm, the indicated rate of the affected products… |
| Jul 13, 2018 | Class II | Z-2895-2018 | Labeling design | Philips has received several reports in which monitors with lithium ion batteries that had exceeded their battery life expectancy have overheated or ignited. These batteries should be replaced every 3 years or upon reaching 300… |
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 · 7 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 16 years and passes through 6 companies; a new generation was cleared every 1.3 years on median.
- 13 of the 65 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K133961 (Philips Medical Systems, 2014) has gone furthest, with 3 descendants of its own.
- 6 other devices also cite its predicate K052707.
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. 2013, 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?
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
* SpO2
* IBP
* CO2
* Temperature
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123900 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123900: Suresigns VM4, Suresigns VM6, Suresigns VM8.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123900
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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