510(k) · Cleared
Recalled · Class II · 2023EarlyVue VS30
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Philips Medizin Systeme Boeblingen GmbH · DSJ Alarm, Blood-Pressure
Cleared on Oct 27, 2019 as substantially equivalent to K163649 (Philips Medical Systems, 2017) and 2 other predicates after a 230-day review. Its family tree reaches back 16 generations to 1997. 1 of the 85 devices in its family, counting itself, has a Class I recall. It has been recalled 3 times.
- Decided
- Oct 27, 2019
- Review
- 230 days
- Class
- Class II
- Product code
- DSJ
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 16 generations to K962603 (1997). 84 ancestors in all, the oldest K853990 (1985). No later device cites it as a predicate yet. 1 of the 85 devices in this family, counting this one, has a Class I recall.
- Root · 16 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 12 generations between
- 3 generations backK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
- 2 generations backK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
- 1 generation backK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · Recalled
- This deviceK190624 EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019
Show all 16 generations
- Root · 16 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 15 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 14 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 13 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 12 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 11 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 10 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 9 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 8 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 7 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 6 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 5 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 4 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 3 generations backK133961 Suresigns VS3, Suresigns VS4Philips Medical Systems · 2014
- 2 generations backK151761 SureSigns VS3, SureSigns VS4Phillips Medical Systems · 2015
- 1 generation backK163649 SureSigns VS3; SureSigns VS4Philips Medical Systems · 2017 · Recalled
- This deviceK190624 EarlyVue VS30Philips Medizin Systeme Boeblingen GmbH · 2019
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −16 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −15 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −14 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −13 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −12 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −11 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −10 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −9 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −8 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −7 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −6 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −5 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −4 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −3 | K133961 | Suresigns VS3, Suresigns VS4 | Philips Medical Systems | 2014 | — |
| −2 | K151761 | SureSigns VS3, SureSigns VS4 | Phillips Medical Systems | 2015 | — |
| −1 | K163649 | SureSigns VS3; SureSigns VS4 | Philips Medical Systems | 2017 | 10 |
| 0 (this device) | K190624 | EarlyVue VS30 | Philips Medizin Systeme Boeblingen GmbH | 2019 | — |
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 |
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? (3)
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 |
|---|---|---|---|
| * | K163649 | SureSigns VS3; SureSigns VS4Summary page 5…Anesthesiology 868.1400, II CCK Analyzer, Gas & Respiratory Therapy 4. Predicate Device: Philips SureSigns VS4 Vital Signs Monitor cleared under K163649, K151761, K133961. Reference Device: Philips Efficia CM patient monitors with 510(k) K151812 5. Product Description… | 2017 |
| * | K151761 | SureSigns VS3, SureSigns VS4Summary page 5…ology 868.1400, II CCK Analyzer, Gas & Respiratory Therapy 4. Predicate Device: Philips SureSigns VS4 Vital Signs Monitor cleared under K163649, K151761, K133961. Reference Device: Philips Efficia CM patient monitors with 510(k) K151812 5. Product Description The su… | 2015 |
| * | K133961 | Suresigns VS3, Suresigns VS4Summary page 5…8.1400, II CCK Analyzer, Gas & Respiratory Therapy 4. Predicate Device: Philips SureSigns VS4 Vital Signs Monitor cleared under K163649, K151761, K133961. Reference Device: Philips Efficia CM patient monitors with 510(k) K151812 5. Product Description The subject device… | 2014 |
| † | K151812 | Patient Monitors Various Models | 2016 |
| † | K051366 | Piconibp Oem Module | 2005 |
| † | K110028 | Masimo Radical Y Pulse CO-Oximeter | 2011 |
| † | K123690 | CAPNOSTREAM20P with Hifi C02 Monitoring | 2014 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (1 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2023 | Class II | Z-2655-2023 | Software design | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. |
| Aug 31, 2023 | Class II | Z-2654-2023 | Software design | A software issue prevents the monitor from alarming when the high/low acoustic respiration rate (RRa) limits are violated. |
| Mar 6, 2023 | Class II | Z-1645-2023 | Software design | EarlyVue VS30 Vital Signs Monitor and EarlyVue VS30 Vitals monitor Missing Calibration Alarm, a risk of an inaccurate CO2 measurement which may lead to a failure to recognize a change in patient condition. |
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 · 8 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 22 years and passes through 9 companies; a new generation was cleared every 1.3 years on median.
- 18 of the 84 ancestors have a recall of any class; 1 has a Class I recall.
How does its category compare?
All DSJ devicesDSJ Alarm, Blood-Pressure: FDA decisions, review times, recalls and adverse event reports over 20 years. 2019, 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 EarlyVue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care settings in which care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use…
Read the full statement (161 words)
The EarlyVue VS30 is intended to measure, display, alarm and, record physiological information of adult, pediatric and neonatal patients in hospitals and in out-of-hospital patient care settings in which care is administered by a healthcare professional (such as clinics, outpatient surgery facilities, long-term care facilities, and physician offices). It is not intended for use in mobile settings such as ambulances and aircraft. Clinical users may use the monitor during patient transport within a healthcare facility.
The intended use of measurement parameters for each patient type is shown in table below (Parameter (patient types)):
Non-invasive BP--NBP (Adult, Pediatric, Neonatal);
SpO2 --Masimo rainbow SET or Philips FAST (Adult, Pediatric, Neonatal);
Pulse Rate --PR--derived from SpO2 or NBP (Adult, Pediatric, Neonatal);
Temperature-Predictive, Temporal (Adult, Pediatric, Neonatal);
end tidal CO2--etCO2 (Adult, Pediatric, Neonatal);
Respiration Rate: airway respiration--awRR (Adult, Pediatric, Neonatal);
Respiration Rate: acoustic respiration--RRa (Adult, Pediatric);
Non-invasive Total Hemoglobin--SpHb (Adult, Pediatric)
Contra-indications: Not for transport outside the healthcare facility. Not for use in home setting.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K190624 · printed Nov 5, 2026
Cite this page
510(k) Report. “K190624: EarlyVue VS30.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K190624
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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