510(k) · Cleared
Recalled · Class II · 2019SureSigns 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 Mar 31, 2017 as substantially equivalent to K151761 (Phillips Medical Systems, 2015) after a 98-day review. Its family tree reaches back 15 generations to 1997. 1 of the 85 devices in its family, counting itself, has a Class I recall. 1 later device descends from it. It has been recalled 10 times.
- Decided
- Mar 31, 2017
- Review
- 98 days
- Class
- Class II
- Product code
- DSJ
- Recalls
- 10
- Predicates
- 1
Its longest line of descent runs back 15 generations to K962603 (1997). 83 ancestors in all, the oldest K853990 (1985). 1 later device descends from it, 1 citing it directly. 1 of the 85 devices in this family, counting this one, has a Class I recall.
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 11 generations between
- 3 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 2 generations backK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
- 1 generation backK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
- This deviceK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017
- Descendant · cites it directly · 0 of its ownK190624 EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019 · Recalled
Show all 15 generations
- Root · 15 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 14 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 13 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 12 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 11 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 10 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 9 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 8 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 7 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 6 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 5 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 4 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 3 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 2 generations backK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
- 1 generation backK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
- This deviceK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017
Class I recalls in this family
- K970209 Capnocheck Plus9 generations back · 1997
Most influential descendants
Showing 1 of 1 · See all- K190624EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −15 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −14 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −13 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −12 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −11 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −10 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −9 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −8 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −7 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −6 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −5 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −4 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −3 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −2 | K133961 | Suresigns VS3, Suresigns VS4 | Philips Medical Systems | 2014 | — |
| −1 | K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015 | — |
| 0 (this device) | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | — |
| +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 |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K151761 | SureSigns VS3, SureSigns VS4Summary page 5…K163649 7. The modified devices are substantially equivalent to previously cleared devices from Philips: SureSigns VS3 Vital Signs Monitor cleared under k151761 SureSigns VS4 Vital Signs Monitor cleared under k151761 8. The modifications are as following: The subject VS3… | 2015 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K190624 | EarlyVue VS30 | 2019 | 0 |
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Apr 19, 2019 | Class II | Z-1324-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Apr 19, 2019 | Class II | Z-1319-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Apr 19, 2019 | Class II | Z-1317-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Apr 19, 2019 | Class II | Z-1318-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Apr 19, 2019 | Class II | Z-1320-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Apr 19, 2019 | Class II | Z-1323-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Apr 19, 2019 | Class II | Z-1321-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Apr 19, 2019 | Class II | Z-1322-2019 | Software design | System software inhibits the monitor and as a result does not measure, display and alarm for pulse rates above 240 beats per minute. |
| Jul 13, 2018 | Class II | Z-2894-2018 | 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… |
| Jul 13, 2018 | Class II | Z-2893-2018 | 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… |
The 5 latest of 10 recalls; the web page lists all.
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 · 9 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 8 companies; a new generation was cleared every 1.1 years on median.
- 17 of the 83 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K190624 (Philips Medizin Systeme Boeblingen GmbH, 2019) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K151761.
How does its category compare?
All DSJ devicesDSJ Alarm, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 SureSignsVS3 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. Parameter (patient types): NBP (Adult, Pediatric…
Read the full statement (173 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 SureSignsVS3 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.
Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal)
Contraindications: Not for transport outside the 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.
Parameter (patient types): NBP (Adult, Pediatric, Neonatal); SpO2 (Adult, Pediatric, Neonatal); Temperature (Adult, Pediatric, Neonatal); CO2 (Adult, Pediatric, Neonatal); RRa (Adult, Pediatric); SpHb (Adult, Pediatric)
Contraindications: Not for transport outside the healthcare facility
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/K163649 · printed Nov 5, 2026
Cite this page
510(k) Report. “K163649: SureSigns VS3; SureSigns VS4.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K163649
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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