510(k) · Cleared
ClearedVSM - Vital Signs Monitor, Model 53000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn Protocol, Inc. · DQA Oximeter
Cleared on Aug 26, 2003 as substantially equivalent to K951193 (Tycos Instruments, Inc., 1996) and 3 other predicates after an 83-day review. Its family tree reaches back 6 generations to 1997. 290 later devices descend from it.
- Decided
- Aug 26, 2003
- Review
- 83 days
- Class
- Class II
- Product code
- DQA
- Recalls
- None
- Predicates
- 4
Its longest line of descent runs back 6 generations to K962603 (1997). 13 ancestors in all, the oldest K904039 (1990). 290 later devices descend from it, 6 citing it directly.
- Root · 6 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 4 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 3 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 2 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 1 generation backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- This deviceK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- Descendant · cites it directly · 175 of its ownK063725 MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · 2 generations on · 151 of its ownK071426 MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007
- Descendant · 2 generations on · 143 of its ownK081793 Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A…Philips Medizin Systeme Boeblingen GmbH · 2008
- Descendant · 2 generations on · 127 of its ownK082633 Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · Recalled
- Descendant · 2 generations on · 125 of its ownK083517 Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · Recalled
Showing 5 of 290 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 290 · See all- K063725MP5 Intellivue Patient MonitorPhilips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · cites it directly175descendants
- K071426MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue Patient…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2007 · 2 generations on151descendants
- K081793Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue Telemetry…Philips Medizin Systeme Boeblingen GmbH · 2008 · 2 generations on143descendants
- K082633Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40, MP50…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2008 · 2 generations on127descendants
- K083517Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60, MP7-, MP80…Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · 2009 · 2 generations on125descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −5 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −4 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −3 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −2 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −1 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| 0 (this device) | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| +1 | K063725 | MP5 Intellivue Patient Monitor | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| +2 | K071426 | MP2, X2, MP5, MP20, MP30, MP40, MP50, MP60, MP70, MP80, and MP90 Intellivue… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2007 | — |
| +2 | K081793 | Philips MP5 and MP5T Intellivue Patient Monitors and TRX4841A Intellivue… | Philips Medizin Systeme Boeblingen GmbH | 2008 | — |
| +2 | K082633 | Intellivue Patient Monitor, Intellivue XDS, Models MP2, MP5, MP20, MP30, MP40… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2008 | 3 |
| +2 | K083517 | Intellivue Patient Monitor, Models MP2, MP5, MP20, MP30, MP40, MP50, MO60… | Philips Medizinsysteme Boeblingen GmbH, Cardiac AN | 2009 | 2 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1990 | 1 | 0 |
| 1995 | 1 | 0 |
| 1996 | 3 | 0 |
| 1999 | 1 | 0 |
| 2003 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2004 | 1 | 0 |
| 2005 | 2 | 0 |
| 2006 | 2 | 0 |
| 2007 | 4 | 0 |
| 2008 | 5 | 0 |
| 2009 | 5 | 0 |
| 2010 | 9 | 0 |
| 2011 | 12 | 0 |
| 2012 | 12 | 0 |
| 2013 | 13 | 0 |
| 2014 | 13 | 0 |
| 2015 | 14 | 0 |
| 2016 | 16 | 0 |
| 2017 | 15 | 0 |
| 2018 | 19 | 0 |
| 2019 | 16 | 0 |
| 2020 | 14 | 0 |
| 2021 | 9 | 0 |
| 2022 | 24 | 0 |
| 2023 | 20 | 0 |
| 2024 | 22 | 0 |
| 2025 | 26 | 0 |
| 2026 | 17 | 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 DQA? 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 DQA device
- #1 K221282 Empatica Health Monitoring Platformscore 20.1 · 38 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against? (4)
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 |
|---|---|---|---|
| * | K951193 | Clinical Vital Signs Monitor, Model #52STP-E1Summary page 1…Classification: Class II Predicate Devices The predicate devices for the model 53000 Series monitors are the Welch Allyn CVSM vital signs monitors model 52STP, K951193, and Protocol Systems Propaq Encore 200 Series, K951246, and Nellcor Puritan Bennett Pulse Oximeter module MP506 cl… | 1996 |
| * | K951246 | Propaq Encore 200 Series Monitor with Neonatal Mode and Impedance Pneumography OptionsSummary page 1…vices for the model 53000 Series monitors are the Welch Allyn CVSM vital signs monitors model 52STP, K951193, and Protocol Systems Propaq Encore 200 Series, K951246, and Nellcor Puritan Bennett Pulse Oximeter module MP506 cleared with Pulse Oximeter Model N-550 K021090, and… | 1996 |
| * | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterSummary page 1…Protocol Systems Propaq Encore 200 Series, K951246, and Nellcor Puritan Bennett Pulse Oximeter module MP506 cleared with Pulse Oximeter Model N-550 K021090, and Welch Allyn SureTempTMPlus, K030580. Device Description The model 53000 Series of monitors are intended to be used b… | 2002 |
| * | K030580 | Suretemp PlusSummary page 1…es, K951246, and Nellcor Puritan Bennett Pulse Oximeter module MP506 cleared with Pulse Oximeter Model N-550 K021090, and Welch Allyn SureTempTMPlus, K030580. Device Description The model 53000 Series of monitors are intended to be used by clinicians and medically qualified personnel… | 2003 |
What descends from it? (290)
See all 2906 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063725 | MP5 Intellivue Patient Monitor | 2007 | 175 |
| K033378 | Vital Signs Monitor, Propaq LT | 2004 | 108 |
| K063419 | Modification to VSM- Vital Signs Monitor, (VSM 300 ) | 2006 | 75 |
| K062095 | Mcare 300 Vital Signs Monitor, Model 91220 | 2006 | 3 |
| K053027 | VSM Vital Signs Monitor, Model 53000 (VSM 300) | 2005 | 3 |
| K051375 | Vital Signs Monitor | 2005 | 3 |
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 6 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 4 of the 13 ancestors have a recall of any class.
- Of its descendants, K063725 (Philips Medizinsysteme Boeblingen GmbH, Cardiac AN, 2007) has gone furthest, with 175 descendants of its own.
- 5 other devices also cite its predicate K951193.
How does its category compare?
All DQA devicesDQA Oximeter: FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · DQA
15in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · DQA
182in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · DQA
3in 2024
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · DQA
399in 2025
MAUDE reports naming product code DQA, 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 | 20 | 122 | 6 | 325 |
| 2008 | 22 | 97 | 5 | 312 |
| 2009 | 35 | 117 | 29 | 281 |
| 2010 | 29 | 127 | 4 | 185 |
| 2011 | 15 | 195 | 1 | 164 |
| 2012 | 14 | 120 | 0 | 322 |
| 2013 | 15 | 182 | 0 | 468 |
| 2014 | 11 | 175 | 2 | 1,124 |
| 2015 | 13 | 158 | 1 | 2,082 |
| 2016 | 14 | 246 | 0 | 1,775 |
| 2017 | 9 | 200 | 0 | 1,190 |
| 2018 | 18 | 260 | 32 | 694 |
| 2019 | 19 | 158 | 0 | 548 |
| 2020 | 15 | 126 | 0 | 426 |
| 2021 | 10 | 174 | 0 | 553 |
| 2022 | 20 | 265 | 0 | 478 |
| 2023 | 13 | 317 | 0 | 392 |
| 2024 | 14 | 285 | 3 | 545 |
| 2025 | 15 | 182 | 0 | 399 |
| 2026 | 8 | 187 | 0 | — |
What is it indicated for?
The VSM series of monitors are intended to be used by clinicians and medically qualified
personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature,
noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO*), and body
temperature in normal and axillary modes of neonatal, pediatric and adult patients.
The most likely locations for patients to be monitored are general med/surg. floors,
general hospital and alternate care environments. This device is available for sale only
upon the order of a physician or licensed health care professional.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K031740 · printed Nov 5, 2026
Cite this page
510(k) Report. “K031740: VSM - Vital Signs Monitor, Model 53000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K031740
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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