510(k) · Cleared
ClearedVital Signs Monitor, Connex Vital Signs Monitor
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 Nov 20, 2013 as substantially equivalent to K121013 (Welch Allyn, Inc., 2012) after a 70-day review. Its family tree reaches back 16 generations to 1997. 1 of the 74 devices in its family, counting itself, has a Class I recall. 6 later devices descend from it.
- Decided
- Nov 20, 2013
- Review
- 70 days
- Class
- Class II
- Product code
- MWI
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 16 generations to K962603 (1997). 67 ancestors in all, the oldest K853990 (1985). 6 later devices descend from it, 3 citing it directly. 1 of the 74 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 backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 2 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 1 generation backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- This deviceK132808 Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc. · 2013
- Descendant · cites it directly · 2 of its ownK171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex…Welch Allyn, Inc. · 2017 · Recalled
- Descendant · cites it directly · 1 of its ownK142356 Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc. · 2014 · Recalled
- Descendant · 2 generations on · 0 of its ownK241411 Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core…Welch Allyn, Inc. · 2024 · Recalled
- Descendant · 2 generations on · 0 of its ownK212473 Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
- Descendant · 2 generations on · 0 of its ownK201635 MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021
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 backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 2 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 1 generation backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- This deviceK132808 Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc. · 2013
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Class I recalls in this family
- K970209 Capnocheck Plus8 generations back · 1997
Most influential descendants
Showing 5 of 6 · See all- K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System…Welch Allyn, Inc. · 2017 · cites it directly2descendants
- K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc. · 2014 · cites it directly1descendant
- K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc. · 2024 · 2 generations on0descendants
- K212473Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022 · 2 generations on0descendants
- K201635MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021 · 2 generations on0descendants
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 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −2 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −1 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| 0 (this device) | K132808 | Vital Signs Monitor, Connex Vital Signs Monitor | Welch Allyn, Inc. | 2013 | — |
| +1 | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall… | Welch Allyn, Inc. | 2017 | 3 |
| +1 | K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | Welch Allyn, Inc. | 2014 | 3 |
| +2 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | Welch Allyn, Inc. | 2024 | 1 |
| +2 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | — |
| +2 | K201635 | MouthLab Vital Signs Monitoring System | Multisensor Diagnostics (Dba Aidar Health) | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1985 | 1 | 0 |
| 1990 | 2 | 0 |
| 1991 | 2 | 0 |
| 1992 | 1 | 0 |
| 1993 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 2 | 1 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 3 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 2 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2019 | 1 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2024 | 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.
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 |
|---|---|---|---|
| * | K121013 | Connex Vital Signs Monitor 6000 SeriesSummary page 1…(21 CFR 870.2300, Product Code MWI) Predicate Device: Connex® Vital Signs Monitor 6000 Series 510(k) Number: K 121013 Electrocardiograph, 21 CFR 870.2300 Class 11,MWI Section 11 5 10(… | 2012 |
| † | K120465 | Earlysense (Everon) System | 2012 |
What descends from it? (6)
3 later devices cite it directly; ranked here by how many devices descend from each in turn.
Has anything in its family been recalled? (1 Class I)
No FDA recall names this device.
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 16 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 14 of the 67 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K171621 (Welch Allyn, Inc., 2017) has gone furthest, with 2 descendants of its own.
- 2 other devices also cite its predicate K121013.
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. 2013, 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 neonatal, pediatric, and adult patients for: - noninvasive blood pressure. - pulse rate, - noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and - body temperature in normal and axillary modes. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and…
Read the full statement (461 words)
The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure.
- pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments.
The optional Masimo Rainbow SET' Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (5p02). pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimno Rainbow SET' Radical 711 Pulse CO-Oximeler and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion and no motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.
The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IN is based on four parameters provided by the monitor: end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pediatric patient's ventilatory status displayed on a scale of I - 10, where t0 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IN' is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g.. Health o meter 0 ) can be used for height, weight, and DM3 input.
The Welch Allyn Connex* Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Fmamework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
The EarlySense (Everon) module is intended ror continuous measurement of respiration rate, heart rate and movement, inan automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation oF the EarlySense has been studied inchildren (weight ? 10 Kg) and adults (weight <1I I Kg) during sleep and resting condition.
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/K132808 · printed Nov 4, 2026
Cite this page
510(k) Report. “K132808: Vital Signs Monitor, Connex Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K132808
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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