# K171621: Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Jun 30, 2017 after 28 days
- Product code: MHX (Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.1025
- Recalls of this device: 3 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 17 generations back to K962603 (1997). 76 ancestors in all.
2 later devices descend from it; 2 cite it directly.
1 of 79 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K132808: Vital Signs Monitor, Connex Vital Signs Monitor, Welch Allyn, Inc. (2013) Summary page 5.
- K152701: Matrix Mini ECG Monitor, Global Instrumentation, LLC (2016) Summary page 5.
- K121013: Connex Vital Signs Monitor 6000 Series, Welch Allyn, Inc. (2012) Summary page 13.

## Most influential descendants
- K212473: Welch Allyn Connex Central Station (2022), 0 descendants of its own
- K201635: MouthLab Vital Signs Monitoring System (2021), 0 descendants of its own

## Recalls of this device
- Mar 24, 2025 · Class II · Z-1558-2025: 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 app
- Mar 21, 2025 · Class II · Z-1563-2025: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.
- Mar 21, 2025 · Class II · Z-1562-2025: Undeclared natural rubber band within the packaging of certain configurations of reusable blood pressure cuffs.

## Indications for use
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.

Source page: https://510kreport.com/device/K171621
Methodology: https://510kreport.com/methodology