510(k) · Cleared
Recalled · Class II · 2025Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Welch Allyn, Inc. · MHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms)
Cleared on Jun 30, 2017 as substantially equivalent to K132808 (Welch Allyn, Inc., 2013) and 2 other predicates after a 28-day review. Its family tree reaches back 17 generations to 1997. 1 of the 79 devices in its family, counting itself, has a Class I recall. 2 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 30, 2017
- Review
- 28 days
- Class
- Class II
- Product code
- MHX
- Recalls
- 3
- Predicates
- 3
Its longest line of descent runs back 17 generations to K962603 (1997). 76 ancestors in all, the oldest K853990 (1985). 2 later devices descend from it, 2 citing it directly. 1 of the 79 devices in this family, counting this one, has a Class I recall.
- Root · 17 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 13 generations between
- 3 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 2 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 1 generation backK132808 Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc. · 2013
- This deviceK171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex…Welch Allyn, Inc. · 2017
- Descendant · cites it directly · 0 of its ownK212473 Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
- Descendant · cites it directly · 0 of its ownK201635 MouthLab Vital Signs Monitoring SystemMultisensor Diagnostics (Dba Aidar Health) · 2021
Show all 17 generations
- Root · 17 generations backK962603 Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & CablesMasimo Corp. · 1997
- 16 generations backK973887 Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and…Masimo Corp. · 1998
- 15 generations backK982255 Model 2000 Pulse OximeterIvy Biomedical Systems, Inc. · 1998
- 14 generations backK991823 N-395 Pulse Oximeter, Model N-395Nellcor Puritan Bennett, Inc. · 1999
- 13 generations backK012891 Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax…Nellcor Puritan Bennett, Inc. · 2002 · Recalled
- 12 generations backK021090 Oximax N-550 Pulse Oximeter,Model N-550 Pulse OximeterNellcor Puritan Bennett, Inc. · 2002
- 11 generations backK033048 Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS…Cas Medical Systems, Inc. · 2004 · Recalled
- 10 generations backK050844 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL…Cas Medical Systems, Inc. · 2005
- 9 generations backK060065 CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One…Oridion Capnography, Inc. · 2006 · Recalled
- 8 generations backK072295 Capnostream 20 with A2 Adaptive Averaging SoftwareOridion Capnography, Inc. · 2007
- 7 generations backK082268 CAPNOSTREAM20 with Integrated Pulmonary IndexOridion Capnography, Inc. · 2009 · Recalled
- 6 generations backK091241 Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse…Masimo Corporation · 2009
- 5 generations backK100428 Masimo Rainbow Set Radical 7R Pulse CO-OximeterMasimo Corporation · 2010
- 4 generations backK110516 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 3 generations backK112687 Connex (R) Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2011
- 2 generations backK121013 Connex Vital Signs Monitor 6000 SeriesWelch Allyn, Inc. · 2012
- 1 generation backK132808 Vital Signs Monitor, Connex Vital Signs MonitorWelch Allyn, Inc. · 2013
- This deviceK171621 Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex…Welch Allyn, Inc. · 2017
Class I recalls in this family
- K970209 Capnocheck Plus3 generations back · 1997
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −17 | K962603 | Masimo Set MS-1 Pulse Oximeter & the Lnop Series of Sensors & Cables | Masimo Corp. | 1997 | — |
| −16 | K973887 | Masimo Set MS-1P Pulse Oximeter and the Lnop Series of Sensors and Cables | Masimo Corp. | 1998 | — |
| −15 | K982255 | Model 2000 Pulse Oximeter | Ivy Biomedical Systems, Inc. | 1998 | — |
| −14 | K991823 | N-395 Pulse Oximeter, Model N-395 | Nellcor Puritan Bennett, Inc. | 1999 | — |
| −13 | K012891 | Oximax Pulse Oximetry System with N-595 Pulse Oximeter and Oximax Sensors and… | Nellcor Puritan Bennett, Inc. | 2002 | 1 |
| −12 | K021090 | Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter | Nellcor Puritan Bennett, Inc. | 2002 | — |
| −11 | K033048 | Cas 740 Series Monitor, Models 740-1, 740M-1, 740-2MS, 740M-2MS, 740-2NL… | Cas Medical Systems, Inc. | 2004 | 1 |
| −10 | K050844 | 750C Series Monitor, Models 750C-2MS, 750CM-2MS, 750C-NNL, 750CM-2NL… | Cas Medical Systems, Inc. | 2005 | — |
| −9 | K060065 | CAPNOSTREAM20 Two Parameter Bedside Monitor & CAPNOSTREAM10 One Parameter… | Oridion Capnography, Inc. | 2006 | 3 |
| −8 | K072295 | Capnostream 20 with A2 Adaptive Averaging Software | Oridion Capnography, Inc. | 2007 | — |
| −7 | K082268 | CAPNOSTREAM20 with Integrated Pulmonary Index | Oridion Capnography, Inc. | 2009 | 9 |
| −6 | K091241 | Masimo Rainbow Set Radical 7 Pulse CO-Oximeter; Rad 87 Pulse CO-Oximeter | Masimo Corporation | 2009 | — |
| −5 | K100428 | Masimo Rainbow Set Radical 7R Pulse CO-Oximeter | Masimo Corporation | 2010 | — |
| −4 | K110516 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −3 | K112687 | Connex (R) Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2011 | — |
| −2 | K121013 | Connex Vital Signs Monitor 6000 Series | Welch Allyn, Inc. | 2012 | — |
| −1 | K132808 | Vital Signs Monitor, Connex Vital Signs Monitor | Welch Allyn, Inc. | 2013 | — |
| 0 (this device) | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall… | Welch Allyn, Inc. | 2017 | — |
| +1 | K212473 | Welch Allyn Connex Central Station | Welch Allyn, Inc. | 2022 | — |
| +1 | 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 | 3 | 0 |
| 1992 | 1 | 0 |
| 1993 | 2 | 0 |
| 1994 | 1 | 0 |
| 1995 | 5 | 0 |
| 1996 | 3 | 0 |
| 1997 | 3 | 1 |
| 1998 | 4 | 0 |
| 1999 | 3 | 0 |
| 2000 | 4 | 0 |
| 2001 | 1 | 0 |
| 2002 | 4 | 0 |
| 2003 | 5 | 0 |
| 2004 | 5 | 0 |
| 2005 | 3 | 0 |
| 2006 | 3 | 0 |
| 2008 | 1 | 0 |
| 2010 | 3 | 0 |
| 2012 | 1 | 0 |
| 2016 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 1 | 0 |
| 2022 | 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 MHX device
- #1 K251702 IntelliVue Patient Monitor MX750; IntelliVue…score 23.0 · 40 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 |
|---|---|---|---|
| * | K132808 | Vital Signs Monitor, Connex Vital Signs MonitorSummary page 5…CFR 870.1025, Product Code MHX) Predicate Device: Connex® Vital Signs Monitor 6000 Series 510(k) Number: K132808 monitor,physiological,patient(without arrhythmia detection or alarms), 21 CFR… | 2013 |
| * | K152701 | Matrix Mini ECG MonitorSummary page 5…Class II, MWI Matrix Mini ECG Monitor 510(k) Number: K152701 Arrhythmia Detector and Alarm (Including ST-Segment Measurement… | 2016 |
| * | K121013 | Connex Vital Signs Monitor 6000 SeriesSummary page 13…Welch Allyn Connex® Vital Signs Monitor 6000 Series is substantially equivalent in operation and performance to the Welch Allyn Vital Signs Monitor 6000 Series monitor (K121013). Subject Device and Predicate Device Comparison Characteristic P… | 2012 |
What descends from it? (2)
2 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Mar 24, 2025 | Class II | Z-1558-2025 | Process design | There were customer reports of devices which experienced battery-related fires. The investigation found that the devices in question were utilizing third-party, after-market batteries that are not approved by Baxter. |
| Mar 21, 2025 | Class II | Z-1563-2025 | Device Design | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
| Mar 21, 2025 | Class II | Z-1562-2025 | Device Design | Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs. |
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 · 3 generations back · ◆ in the 1997 ancestors bar of FIG. 11 Class I recall
What does this lineage say?
- The line of descent spans 20 years and passes through 7 companies; a new generation was cleared every 11 months on median.
- 16 of the 76 ancestors have a recall of any class; 1 has a Class I recall.
- Of its descendants, K212473 (Welch Allyn, Inc., 2022) has gone furthest, with 0 descendants of its own.
- 2 other devices also cite its predicate K132808.
How does its category compare?
All MHX devicesMHX Monitor, Physiological, Patient (With Arrhythmia Detection Or Alarms): FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, this device’s year, is highlighted.
FDA decisions per year · MHX
8in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · MHX
192in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · MHX
21so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · MHX
3,761in 2025
MAUDE reports naming product code MHX, 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 | 15 | 96 | 3 | 131 |
| 2008 | 16 | 58 | 2 | 232 |
| 2009 | 13 | 57 | 7 | 382 |
| 2010 | 20 | 90 | 13 | 955 |
| 2011 | 12 | 81 | 16 | 949 |
| 2012 | 16 | 88 | 11 | 676 |
| 2013 | 21 | 120 | 14 | 1,997 |
| 2014 | 13 | 248 | 6 | 1,609 |
| 2015 | 14 | 203 | 5 | 1,284 |
| 2016 | 13 | 149 | 7 | 1,105 |
| 2017 | 14 | 134 | 6 | 1,115 |
| 2018 | 11 | 203 | 12 | 2,157 |
| 2019 | 7 | 243 | 6 | 1,462 |
| 2020 | 11 | 196 | 0 | 1,714 |
| 2021 | 5 | 195 | 0 | 2,423 |
| 2022 | 15 | 189 | 6 | 1,470 |
| 2023 | 8 | 229 | 3 | 2,254 |
| 2024 | 5 | 181 | 3 | 2,814 |
| 2025 | 8 | 192 | 15 | 3,761 |
| 2026 | 14 | 205 | 21 | — |
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 (Sp0O2), 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 (564 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 (Sp0O2), 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 (SpO2), pulse rate, total hemoglobin concentration
(SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter 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 IPI 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 1 - 10, where 10 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 IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications
Framework ("Framework"). The Framework 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 for continuous measurement of respiration rate, heart rate and movement. in
an 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 in children (weight > 10 Kg) and adults (weight <111 Kg)
during sleep and resting condition.
The.Welch Allyn ECG/Impedance Respiration module and associated software acquires and analyzes ECG signals from
patients. Patients are people with coronary problems, suspected coronary problems, or recent medical procedures that
require cardiac monitoring.
This ECG module can be used on adult and pediatric patients.
The ECG module is indicated for use by healthcare professionals whenever there is aneed to monitor a patient’s
physiological parameters for the following:
« ECG
« ECG with alarms for ventricular tachycardia, ventricular fibrillation, and asystole
*» Impedance respiration
Handle module assembly (Connex Integrated Wall System 8000 series only - Handle Module) - Handles supply power to
Welch Allyn 3.5V instruments.
This product is available for sale only upon the order of a physician or licensed health care professional.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K171621 · printed Nov 6, 2026
Cite this page
510(k) Report. “K171621: Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K171621
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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