510(k) · Cleared
Recalled · Class II · 2018Philips Suresigns VSV (Vital Signs Viewer)
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 Mar 20, 2007 as substantially equivalent to K921014 (Hewlett-Packard Co., 1992) after a 19-day review. Its family tree reaches back 1 generation to 1992. 2 later devices descend from it. It has been recalled 2 times.
- Decided
- Mar 20, 2007
- Review
- 19 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 2
- Predicates
- 1
Its longest line of descent runs back 1 generation to K921014 (1992). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK921014 Model M2350A and M2360A Wavevue Central MonitorHewlett-Packard Co. · 1992
- This deviceK070588 Philips Suresigns VSV (Vital Signs Viewer)Philips Medical Systems · 2007
- Descendant · cites it directly · 1 of its ownK131032 Philips Suresigns CentralPhilips Medical Systems · 2013
- Descendant · 2 generations on · 0 of its ownK160951 Philips Efficia CMS200 Central Monitoring SystemPhilips Medical Systems · 2016 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K921014 | Model M2350A and M2360A Wavevue Central Monitor | Hewlett-Packard Co. | 1992 | — |
| 0 (this device) | K070588 | Philips Suresigns VSV (Vital Signs Viewer) | Philips Medical Systems | 2007 | — |
| +1 | K131032 | Philips Suresigns Central | Philips Medical Systems | 2013 | — |
| +2 | K160951 | Philips Efficia CMS200 Central Monitoring System | Philips Medical Systems | 2016 | 1 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2013 | 1 | 0 |
| 2016 | 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? (1)
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 |
|---|---|---|---|
| * | K921014 | Model M2350A and M2360A Wavevue Central MonitorSummary page 1…__ ___ _ P ys ological Monitors 3. The new device is substantially equivalent to the previously cleared M2350A and Model M2360A, Component Central Monitor (K(921014); 4. The modification is a change that provides support for the Philips SureSigns VM Series Patient Monitors (1(052707) 5. T… | 1992 |
| † | K052707 | M3046B Compact Portable Patient Monitors | 2005 |
| † | K062271 | M3290A Intellivue Information Center Software, Release J.00 (for M3140, M3145, M3150… | 2006 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K131032 | Philips Suresigns Central | 2013 | 1 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 13, 2018 | Class II | Z-2892-2018 | 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… |
| Oct 30, 2009 | Not classified | Z-0373-2010 | Software design | Use of these devices at their maximum volume setting may result in the premature failure of the internal speaker |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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. 2007, 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 central monitoring of multiple adult, pediatric, and neonatal patients, and where the clinician decides to monitor cardiac arrhythmia of adult, pediatric, and neonatal patients to gain information for treatment, to monitor adequacy of treatment, or to exclude causes of symptoms.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070588 · printed Nov 6, 2026
Cite this page
510(k) Report. “K070588: Philips Suresigns VSV (Vital Signs Viewer).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K070588
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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