510(k) · Cleared
Recalled · 2008M3046B Compact Portable Patient Monitors
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 Oct 20, 2005 as substantially equivalent to K971910 (Hewlett-Packard GmbH, 1998) and 9 other predicates after a 21-day review. Its family tree reaches back 5 generations to 1994. 21 later devices descend from it. It has been recalled once.
- Decided
- Oct 20, 2005
- Review
- 21 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 1
- Predicates
- 10
Its longest line of descent runs back 5 generations to K941811 (1994). 22 ancestors in all, the oldest K903523 (1990). 21 later devices descend from it, 7 citing it directly.
- Root · 5 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 4 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 3 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 2 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 1 generation backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- This deviceK052707 M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 2005
- Descendant · cites it directly · 18 of its ownK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · Recalled
- Descendant · cites it directly · 14 of its ownK090483 Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor…Philips Medical Systems · 2009 · Recalled
- Descendant · cites it directly · 11 of its ownK082280 Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor…Philips Medical Systems North America Co. · 2008
- Descendant · cites it directly · 7 of its ownK101067 Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064…Philips Medical Systems · 2010 · Recalled
- Descendant · 2 generations on · 6 of its ownK120132 Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems · 2012
Showing 5 of 21 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 21 · See all- K080495Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · cites it directly18descendants
- K090483Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series…Philips Medical Systems · 2009 · cites it directly14descendants
- K082280Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital…Philips Medical Systems North America Co. · 2008 · cites it directly11descendants
- K101067Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068Philips Medical Systems · 2010 · cites it directly7descendants
- K120132Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorPhilips Medical Systems · 2012 · 2 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −4 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −3 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −2 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −1 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| 0 (this device) | K052707 | M3046B Compact Portable Patient Monitors | Philips Medical Systems | 2005 | — |
| +1 | K080495 | Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 | Philips Medical Systems | 2008 | 1 |
| +1 | K090483 | Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns… | Philips Medical Systems | 2009 | 5 |
| +1 | K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns… | Philips Medical Systems North America Co. | 2008 | — |
| +1 | K101067 | Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065… | Philips Medical Systems | 2010 | 1 |
| +2 | K120132 | Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs Monitor | Philips Medical Systems | 2012 | — |
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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 6 | 0 |
| 2012 | 1 | 0 |
| 2013 | 2 | 0 |
| 2014 | 1 | 0 |
| 2015 | 1 | 0 |
| 2016 | 3 | 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.
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
What was it cleared against? (10)
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 |
|---|---|---|---|
| * | K971910 | Multi-Parameter Module (M3000A)/Display Unit (M3046A)Summary page 1…Clinical Personal Use 3. The modified devices are substantially equivalent to previously cleared Philips devices marketed pursuant to K971910, 47 K981576, K990972, K991773, K992273, K99338… | 1998 |
| * | K981576 | Multi-Parameter Module, Model M3000A & Display Unit, Model M3046ASummary page 2…antially equivalent to previously cleared Philips devices marketed pursuant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of… | 1998 |
| * | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 2…equivalent to previously cleared Philips devices marketed pursuant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B… | 1999 |
| * | K991773 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia…Summary page 2…t to previously cleared Philips devices marketed pursuant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B.00 softw… | 1999 |
| * | K992273 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor…Summary page 2…usly cleared Philips devices marketed pursuant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B.00 software for the… | 2000 |
| * | K993383 | HP Viridia Multi-Measurement Server/Compact Portable Patient Monitor Models M3000A…Summary page 2…d Philips devices marketed pursuant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B.00 software for the Philips M3… | 2000 |
| * | K000822 | Agilentcomponent Monitoring System, Agilent 24/26, Agilent Multi-Measurement Server and…Summary page 2…evices marketed pursuant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B.00 software for the Philips M3046B Compac… | 2000 |
| * | K001057 | Agilent Information Center Software for M3150A and M3153A and Agilent M2/M3/M4 Compact…Summary page 2…eted pursuant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable… | 2000 |
| * | K001333 | Agilent Component Monitoring System, Agilent Multi-Measurement Server and Compact…Summary page 2…uant to K971910, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable Patient M… | 2000 |
| * | K003621 | ST/AR ST and Arrhythmia Software, Model Release D.0Summary page 2…10, 47 K981576, K990972, K991773, K992273, K993383, K000822, K001057, K001333, and K003621. 4. The modification is the introduction of Release B.00 software for the Philips M3046B Compact Portable Patient Monitors and A… | 2000 |
What descends from it? (21)
See all 217 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K080495 | Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 | 2008 | 18 |
| K090483 | Sursigns VS2 Vital Signs Monitor, Suresigns VS3 Vital Signs Monitor, Suresigns VM Series… | 2009 | 14 |
| K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns VS3 Cital… | 2008 | 11 |
| K101067 | Suresigns VM4, Suresigns VM6, Suresigns VM8 Model: 863063, 863064, 863065, 863066, 863068 | 2010 | 7 |
| K103652 | Suresigns VM Series Patient Monitors, Suresigns VM4, Suresigns VM6, and Suresigns VM8 | 2011 | 6 |
| K123900 | Suresigns VM4, Suresigns VM6, Suresigns VM8 | 2013 | 5 |
| K131913 | Intellivue CL SPO2 Pod and CL NBP Pod, Philips Intellivue Patient Monitors MP5, MP5T… | 2013 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 30, 2008 | Not classified | Z-1911-2008 | Labeling design | Some users of SureSigns VS3 Signs Monitor may have assumed that the SpO2 Non-Pulsatile and SpO2 No Sensor technical alarms were enabled when the SureSigns VS3 Vital Signs Monitor was not in Interval non-invasive blood pressure (NBP) mode.… |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 11 years and passes through 3 companies; a new generation was cleared every 2.1 years on median.
- 1 of the 22 ancestors has a recall of any class.
- Of its descendants, K080495 (Philips Medical Systems, 2008) has gone furthest, with 18 descendants of its own.
- 11 other devices also cite its predicate K971910.
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.
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.
Intended use: For monitoring, recording and alarming of multiple physiological parameters of adults, pediatrics and neonates in healthcare environments. Additionally, the monitor may be used in transport situations within a healthcare facility.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K052707 · printed Nov 5, 2026
Cite this page
510(k) Report. “K052707: M3046B Compact Portable Patient Monitors.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K052707
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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