510(k) · Cleared
Recalled · 2009Modification to VSM- Vital Signs Monitor, (VSM 300 )
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn Protocol, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Dec 4, 2006 as substantially equivalent to K031740 (Welch Allyn Protocol, Inc., 2003) after a 21-day review. Its family tree reaches back 7 generations to 1997. 75 later devices descend from it. It has been recalled once.
- Decided
- Dec 4, 2006
- Review
- 21 days
- Class
- Class II
- Product code
- MWI
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 7 generations to K962603 (1997). 14 ancestors in all, the oldest K904039 (1990). 75 later devices descend from it, 2 citing it directly.
- Root · 7 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 6 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 5 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 4 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 3 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 2 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 1 generation backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- This deviceK063419 Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc. · 2006
- Descendant · cites it directly · 74 of its ownK093907 Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010
- Descendant · cites it directly · 73 of its ownK101445 Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010
- Descendant · 2 generations on · 67 of its ownK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- Descendant · 3 generations on · 66 of its ownK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- Descendant · 4 generations on · 65 of its ownK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
Showing 5 of 75 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 75 · See all- K093907Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010 · cites it directly74descendants
- K101445Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010 · cites it directly73descendants
- K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 2 generations on67descendants
- K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 3 generations on66descendants
- K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012 · 4 generations on65descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −6 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −5 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −4 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −3 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −2 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −1 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| 0 (this device) | K063419 | Modification to VSM- Vital Signs Monitor, (VSM 300 ) | Welch Allyn Protocol, Inc. | 2006 | — |
| +1 | K093907 | Welch Allyn Non Invasive Blood Pressure (Nibp) Device | Welch Allyn, Inc. | 2010 | — |
| +1 | K101445 | Vital Signs Monitor-VSM 6000 Series | Welch Allyn, Inc. | 2010 | — |
| +2 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| +3 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| +4 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
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 |
|---|---|---|
| 2010 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 2 | 0 |
| 2013 | 1 | 0 |
| 2014 | 3 | 0 |
| 2015 | 1 | 0 |
| 2016 | 4 | 0 |
| 2017 | 4 | 0 |
| 2018 | 2 | 0 |
| 2019 | 7 | 0 |
| 2020 | 5 | 0 |
| 2021 | 2 | 0 |
| 2022 | 10 | 0 |
| 2023 | 6 | 0 |
| 2024 | 10 | 0 |
| 2025 | 8 | 0 |
| 2026 | 6 | 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 MWI? 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 MWI device
- #1 K230457 Empatica Health Monitoring Platform…score 28.0 · 39 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin 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 |
|---|---|---|---|
| * | K031740 | VSM - Vital Signs Monitor, Model 53000 SeriesSummary page 1…Protocol, Inc.'s VSM Vital Signs Monitor, Model 53000 Series, which was cleared for marketing under 510(k) K031740. The subject device incorporates a modified noninvasive blood pressure (NIBP) module. The… | 2003 |
What descends from it? (75)
See all 752 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jul 28, 2009 | Not classified | Z-1873-2009 | Device Design | The Welch Allyn VSM300 Vital Signs Monitor may experience a loss of audio which includes a loss of audio alarms. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 9 years and passes through 4 companies; a new generation was cleared every 11 months on median.
- 4 of the 14 ancestors have a recall of any class.
- Of its descendants, K093907 (Welch Allyn, Inc., 2010) has gone furthest, with 74 descendants of its own.
- 5 other devices also cite its predicate K031740.
How does its category compare?
All MWI devicesMWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years.
FDA decisions per year · MWI
4in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MWI
247in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MWI
9so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MWI
182in 2025
MAUDE reports naming product code MWI, 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 | 9 | 42 | 1 | 3 |
| 2008 | 9 | 49 | 1 | 3 |
| 2009 | 6 | 112 | 2 | 20 |
| 2010 | 17 | 58 | 2 | 17 |
| 2011 | 11 | 78 | 3 | 16 |
| 2012 | 13 | 104 | 5 | 31 |
| 2013 | 20 | 85 | 3 | 42 |
| 2014 | 16 | 148 | 6 | 30 |
| 2015 | 19 | 127 | 1 | 31 |
| 2016 | 12 | 165 | 0 | 51 |
| 2017 | 13 | 205 | 2 | 85 |
| 2018 | 11 | 217 | 0 | 158 |
| 2019 | 14 | 255 | 4 | 169 |
| 2020 | 8 | 138 | 0 | 110 |
| 2021 | 9 | 161 | 0 | 188 |
| 2022 | 5 | 231 | 2 | 168 |
| 2023 | 8 | 250 | 0 | 179 |
| 2024 | 10 | 202 | 5 | 120 |
| 2025 | 4 | 247 | 0 | 182 |
| 2026 | 6 | 239 | 9 | — |
What is it indicated for?
The VSM series of monitors is 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 (SpO2), 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 medical and surgical 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/K063419 · printed Nov 4, 2026
Cite this page
510(k) Report. “K063419: Modification to VSM- Vital Signs Monitor, (VSM 300 ).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K063419
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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