510(k) · Cleared
ClearedVital Signs Monitor-VSM 6000 Series
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)
Cleared on Jun 8, 2010 as substantially equivalent to K063419 (Welch Allyn Protocol, Inc., 2006) and 2 other predicates after a 15-day review. Its family tree reaches back 9 generations to 1997. 73 later devices descend from it.
- Decided
- Jun 8, 2010
- Review
- 15 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 9 generations to K962603 (1997). 19 ancestors in all, the oldest K904039 (1990). 73 later devices descend from it, 3 citing it directly.
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 5 generations between
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK063419 Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc. · 2006 · Recalled
- 1 generation backK093907 Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010
- This deviceK101445 Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010
- Descendant · cites it directly · 67 of its ownK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- Descendant · 2 generations on · 66 of its ownK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- Descendant · 3 generations on · 65 of its ownK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- Descendant · 4 generations on · 58 of its ownK140188 Masimo Root Monitoring SystemMasimo Corporation · 2014
- Descendant · 5 generations on · 51 of its ownK142394 Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014
Show all 9 generations
- Root · 9 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 8 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 7 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 6 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 5 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 4 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 3 generations backK031740 VSM - Vital Signs Monitor, Model 53000 SeriesWelch Allyn Protocol, Inc. · 2003
- 2 generations backK063419 Modification to VSM- Vital Signs Monitor, (VSM 300 )Welch Allyn Protocol, Inc. · 2006 · Recalled
- 1 generation backK093907 Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceWelch Allyn, Inc. · 2010
- This deviceK101445 Vital Signs Monitor-VSM 6000 SeriesWelch Allyn, Inc. · 2010
Showing 5 of 73 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 73 · See all- K110516Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · cites it directly67descendants
- K112687Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011 · 2 generations on66descendants
- K121013Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012 · 3 generations on65descendants
- K140188Masimo Root Monitoring SystemMasimo Corporation · 2014 · 4 generations on58descendants
- K142394Masimo Root Monitoring System and AccesoriesMasimo Corporation · 2014 · 5 generations on51descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −9 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −8 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −7 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −6 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −5 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −4 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −3 | K031740 | VSM - Vital Signs Monitor, Model 53000 Series | Welch Allyn Protocol, Inc. | 2003 | — |
| −2 | K063419 | Modification to VSM- Vital Signs Monitor, (VSM 300 ) | Welch Allyn Protocol, Inc. | 2006 | 1 |
| −1 | K093907 | Welch Allyn Non Invasive Blood Pressure (Nibp) Device | Welch Allyn, Inc. | 2010 | — |
| 0 (this device) | K101445 | Vital Signs Monitor-VSM 6000 Series | Welch Allyn, Inc. | 2010 | — |
| +1 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| +2 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| +3 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| +4 | K140188 | Masimo Root Monitoring System | Masimo Corporation | 2014 | — |
| +5 | K142394 | Masimo Root Monitoring System and Accesories | Masimo Corporation | 2014 | — |
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 |
| 2000 | 1 | 0 |
| 2003 | 2 | 0 |
| 2004 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (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 |
|---|---|---|---|
| * | K063419 | Modification to VSM- Vital Signs Monitor, (VSM 300 )Summary page 1…ns monitors are: • Welch Allyn VSM- Vital Signs Monitor (VSM 300) 53000 series cleared through FDA 5 10(k) no. K063419 • Welch Allyn Non-invasive Blood Pressure (NIBP) Device cleared through… | 2006 |
| * | K093907 | Welch Allyn Non Invasive Blood Pressure (Nibp) DeviceSummary page 1…FDA 5 10(k) no. K063419 • Welch Allyn Non-invasive Blood Pressure (NIBP) Device cleared through FDA 5 10(k) no. K093907 * Welch Allyn Spot Ultra Vital Signs Device cleared through FDA 5 10(k)… | 2010 |
| * | K040490 | Welch Allyn Spot Ultra Vital Signs DeviceSummary page 1…through FDA 5 10(k) no. K093907 * Welch Allyn Spot Ultra Vital Signs Device cleared through FDA 5 10(k) no. K040490 Description: The Welch Allyn VSM 6000 series is designed to provide a scalable, modular… | 2004 |
What descends from it? (73)
See all 733 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)
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 13 years and passes through 5 companies; a new generation was cleared every 11 months on median.
- 5 of the 19 ancestors have a recall of any class.
- Of its descendants, K110516 (Welch Allyn, Inc., 2011) has gone furthest, with 67 descendants of its own.
- 1 other device also cites its predicate K063419.
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. 2010, this device’s year, is highlighted.
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 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, 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 product 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/K101445 · printed Nov 3, 2026
Cite this page
510(k) Report. “K101445: Vital Signs Monitor-VSM 6000 Series.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 3, 2026. https://510kreport.com/device/K101445
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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