510(k) · Cleared
Recalled · Class II · 2017Suresigns VS2+ -Suresigns Vsi
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DXN System, Measurement, Blood-Pressure, Non-Invasive
Cleared on Oct 11, 2011 as substantially equivalent to K111114 (Philips Medical Systems, 2011) and 1 other predicate after a 29-day review. Its family tree reaches back 9 generations to 1994. It has been recalled 3 times.
- Decided
- Oct 11, 2011
- Review
- 29 days
- Class
- Class II
- Product code
- DXN
- Recalls
- 3
- Predicates
- 2
Its longest line of descent runs back 9 generations to K941811 (1994). 28 ancestors in all, the oldest K903523 (1990). No later device cites it as a predicate yet.
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 5 generations between
- 3 generations backK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · Recalled
- 2 generations backK082280 Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor…Philips Medical Systems North America Co. · 2008
- 1 generation backK111114 Suresigns VS2 Vital Signs MonitorPhilips Medical Systems · 2011
- This deviceK112652 Suresigns VS2+ -Suresigns VsiPhilips Medical Systems · 2011
Show all 9 generations
- Root · 9 generations backK941811 HP M1175A, M1176A, Component Monitoring SystemHewlett-Packard Co. · 1994
- 8 generations backK960934 HP M1205A Omnicare Component Monitor System Model 24Hewlett-Packard Co. · 1996
- 7 generations backK981376 Hewlett-Packard M1205A Viridia 24 CTHewlett-Packard Co. · 1999
- 6 generations backK990125 HP Viridia Component Monitoring System, Model Rev. KHewlett-Packard GmbH · 1999
- 5 generations backK990972 HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP…Hewlett-Packard GmbH · 1999
- 4 generations backK052707 M3046B Compact Portable Patient MonitorsPhilips Medical Systems · 2005 · Recalled
- 3 generations backK080495 Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3Philips Medical Systems · 2008 · Recalled
- 2 generations backK082280 Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor…Philips Medical Systems North America Co. · 2008
- 1 generation backK111114 Suresigns VS2 Vital Signs MonitorPhilips Medical Systems · 2011
- This deviceK112652 Suresigns VS2+ -Suresigns VsiPhilips Medical Systems · 2011
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K941811 | HP M1175A, M1176A, Component Monitoring System | Hewlett-Packard Co. | 1994 | — |
| −8 | K960934 | HP M1205A Omnicare Component Monitor System Model 24 | Hewlett-Packard Co. | 1996 | — |
| −7 | K981376 | Hewlett-Packard M1205A Viridia 24 CT | Hewlett-Packard Co. | 1999 | — |
| −6 | K990125 | HP Viridia Component Monitoring System, Model Rev. K | Hewlett-Packard GmbH | 1999 | — |
| −5 | K990972 | HP Viridia Component Monitoring System, HP Viridia CMS 24/26, HP Viridia… | Hewlett-Packard GmbH | 1999 | — |
| −4 | K052707 | M3046B Compact Portable Patient Monitors | Philips Medical Systems | 2005 | 1 |
| −3 | K080495 | Suresigns VM Series Patient Monitor, Models VM4, VM6, VM8, VM3 and VS3 | Philips Medical Systems | 2008 | 1 |
| −2 | K082280 | Suresigns VS2 Vital Signs Monitor, Suresigns VM1 Patient Monitor, Suresigns… | Philips Medical Systems North America Co. | 2008 | — |
| −1 | K111114 | Suresigns VS2 Vital Signs Monitor | Philips Medical Systems | 2011 | — |
| 0 (this device) | K112652 | Suresigns VS2+ -Suresigns Vsi | Philips Medical Systems | 2011 | — |
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 |
| 2011 | 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 DXN? 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 DXN device
- #1 K222125 Arm Blood Pressure Monitor, models AOJ-30A…score 18.5 · 8 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (2)
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.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 20, 2017 | Class III | Z-0268-2018 | Error in labeling | Some SureSigns VSi, VS2+ products have the Date of Manufacture on its serial number label as %DoM , instead of the specific date in the format of YYYY-MM. |
| Jan 14, 2013 | Class II | Z-0824-2013 | Software design | VS2+ screen may lock up and stop monitoring during patient use |
| Aug 15, 2012 | Class II | Z-2303-2012 | Process design | Philips SureSigns VSi/VS2+ patient monitors may not be properly secured and may fall from the wall mount |
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.
- 4 of the 28 ancestors have a recall of any class.
How does its category compare?
All DXN devicesDXN System, Measurement, Blood-Pressure, Non-Invasive: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · DXN
28in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DXN
142in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DXN
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DXN
239in 2025
MAUDE reports naming product code DXN, 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 | 27 | 118 | 0 | 21 |
| 2008 | 23 | 82 | 1 | 8 |
| 2009 | 46 | 73 | 3 | 17 |
| 2010 | 43 | 94 | 0 | 14 |
| 2011 | 34 | 72 | 1 | 10 |
| 2012 | 36 | 116 | 0 | 19 |
| 2013 | 34 | 150 | 1 | 72 |
| 2014 | 29 | 133 | 0 | 47 |
| 2015 | 30 | 97 | 0 | 62 |
| 2016 | 30 | 144 | 1 | 54 |
| 2017 | 33 | 184 | 0 | 90 |
| 2018 | 22 | 235 | 0 | 617 |
| 2019 | 33 | 156 | 1 | 96 |
| 2020 | 24 | 198 | 0 | 130 |
| 2021 | 23 | 190 | 0 | 162 |
| 2022 | 25 | 137 | 0 | 155 |
| 2023 | 35 | 182 | 0 | 162 |
| 2024 | 17 | 107 | 3 | 270 |
| 2025 | 28 | 142 | 0 | 239 |
| 2026 | 29 | 147 | 0 | — |
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:
* NBP
* Spa 2
* Temperature
Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Standard and optional parameters include:
* NBP
* SpO2
* Temperature
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K112652 · printed Nov 3, 2026
Cite this page
510(k) Report. “K112652: Suresigns VS2+ -Suresigns Vsi.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K112652
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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