510(k) · Cleared
ClearedSuresigns VS3, Suresigns VS4
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medical Systems · DSJ Alarm, Blood-Pressure
Cleared on Jun 26, 2014 as substantially equivalent to K120132 (Philips Medical Systems, 2012) and 4 other predicates after a 184-day review. Its family tree reaches back 13 generations to 1997. 1 of the 85 devices in its family, counting itself, has a Class I recall. 3 later devices descend from it.
- Decided
- Jun 26, 2014
- Review
- 184 days
- Class
- Class II
- Product code
- DSJ
- Recalls
- None
- Predicates
- 5
Its longest line of descent runs back 13 generations to K962603 (1997). 81 ancestors in all, the oldest K853990 (1985). 3 later devices descend from it, 2 citing it directly. 1 of the 85 devices in this family, counting this one, has a Class I recall.
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 9 generations between
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 1 generation backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- This deviceK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
- Descendant · cites it directly · 2 of its ownK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
- Descendant · 2 generations on · 1 of its ownK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · Recalled
- Descendant · cites it directly · 0 of its ownK190624 EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019 · Recalled
Show all 13 generations
- Root · 13 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 11 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 10 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 9 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 8 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 7 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 6 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 5 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 4 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 3 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 2 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 1 generation backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- This deviceK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
Class I recalls in this family
- K970209 Capnocheck Plus7 generations back · 1997
Most influential descendants
Showing 3 of 3 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −13 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −12 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −11 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −10 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −9 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −8 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −7 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −6 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −5 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −4 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −3 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −2 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −1 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| 0 (this device) | K133961 | Suresigns VS3, Suresigns VS4 | Philips Medical Systems | 2014 | — |
| +1 | K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015 | — |
| +2 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 10 |
| +1 | K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019 | 3 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 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 | 8 | 0 |
| 2001 | 1 | 0 |
| 2002 | 2 | 0 |
| 2003 | 2 | 0 |
| 2004 | 3 | 0 |
| 2005 | 3 | 0 |
| 2006 | 2 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 2 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2013 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2015 | 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.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
What was it cleared against? (5)
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 |
|---|---|---|---|
| * | K120132 | Suresigns VS3 Vital Signs Monitor, Suresigns VS4 Vital Signs MonitorSummary page 1…he modified devices are substantially equivalent to previously cleared devices from Philips and suppliers: SureSigns VS3 Vital Signs Monitor cleared under K1 20132 SureSigns VS4 Vital Signs Monitor cleared under 1120132 SureSigns VM8 Patient Monitor cleared under K123900 P… | 2012 |
| * | K123900 | Suresigns VM4, Suresigns VM6, Suresigns VM8Summary page 1…eSigns VS3 Vital Signs Monitor cleared under K1 20132 SureSigns VS4 Vital Signs Monitor cleared under 1120132 SureSigns VM8 Patient Monitor cleared under K123900 Page 1of 3 Philips SureSigns VS3 and VS4 Traditional 510K 01 151 0(k) Summary Mas… | 2013 |
| * | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-OximeterSummary page 2…3 Philips SureSigns VS3 and VS4 Traditional 510K 01 151 0(k) Summary Masimo Rainbow SET Radical 7R CO-Oximeter cleared under K100428 Exergen TemporalScanner Thermometer cleared under K01 1291 Oridion Capnography Inc for Capnostream 20 with microMediCO2 mod… | 2010 |
| * | K011291 | Temporalscanner Thermometer, SensortouchSummary page 2…ditional 510K 01 151 0(k) Summary Masimo Rainbow SET Radical 7R CO-Oximeter cleared under K100428 Exergen TemporalScanner Thermometer cleared under K01 1291 Oridion Capnography Inc for Capnostream 20 with microMediCO2 module cleared under K094012 8. The modifications are as foll… | 2001 |
| * | K094012 | CAPNOSTREAM20 with MICROMEDICO2 ModuleSummary page 2…eared under K100428 Exergen TemporalScanner Thermometer cleared under K01 1291 Oridion Capnography Inc for Capnostream 20 with microMediCO2 module cleared under K094012 8. The modifications are as follows: a) Add CO2 measurement to V54. This is achieved by using the Oridion MicroMed… | 2010 |
| † | K120984 | Masimo Ras-125C Acoustic Respiration Sensor | 2013 |
What descends from it? (3)
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)
No FDA recall names this device.
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 17 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 17 of the 81 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K151761 (Phillips Medical Systems, 2015) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K120132.
How does its category compare?
All DSJ devicesDSJ Alarm, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2014, this device’s year, is highlighted.
FDA decisions per year · DSJ
1in 2019
2026 to Oct 25, outlined.
Median 510(k) review, days · DSJ
Too few DSJ 510(k)s in any year since 2007 to give a median.
Recalls per year · DSJ
No recall names DSJ since 2007.
Adverse event reports per year · DSJ
6in 2025
MAUDE reports naming product code DSJ, 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 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 1 | — | 0 | 0 |
| 2015 | 1 | — | 0 | 2 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 1 | — | 0 | 1 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 1 | — | 0 | 2 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 32 |
| 2022 | 0 | — | 0 | 27 |
| 2023 | 0 | — | 0 | 16 |
| 2024 | 0 | — | 0 | 30 |
| 2025 | 0 | — | 0 | 6 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility. The SureSigns VS4 vital signs monitor is for use…
Read the full statement (118 words)
The SureSigns VS3 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS3 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. Additionally, the monitor may be used in transport situations within a healthcare facility.
The SureSigns VS4 vital signs monitor is for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients. The SureSigns VS4 is for monitoring, recording and alarming of multiple physiological parameters in healthcare environments for patient types listed below. 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/K133961 · printed Nov 6, 2026
Cite this page
510(k) Report. “K133961: Suresigns VS3, Suresigns VS4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K133961
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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