# K121013: Connex Vital Signs Monitor 6000 Series

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Jul 26, 2012 after 114 days
- Product code: MWI (Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms))
- Device class: 2
- Regulation: 21 CFR 870.2300
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 15 generations back to K962603 (1997). 66 ancestors in all.
65 later devices descend from it; 3 cite it directly.
1 of 132 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112687: Connex (R) Vital Signs Monitor 6000 Series, Welch Allyn, Inc. (2011)
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 1.
- K094012: CAPNOSTREAM20 with MICROMEDICO2 Module, Oridion Capnography, Inc. (2010) Summary page 1.
- K033378: Vital Signs Monitor, Propaq LT, Welch Allyn Protocol, Inc. (2004) Summary page 1.

## Most influential descendants
- K140188: Masimo Root Monitoring System (2014), 58 descendants of its own
- K142394: Masimo Root Monitoring System and Accesories (2014), 51 descendants of its own
- K151644: Masimo Root Vital Signs Monitoring System and Accessories (2016), 24 descendants of its own
- K150314: Masimo MightySat Rx Fingertip Pulse Oximeter (2015), 24 descendants of its own
- K181956: Masimo MightySat Rx Fingertip Pulse Oximeter (2019), 23 descendants of its own

## 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 (Sp02), 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. Monitoring can be accomplished on the VSM 6000 series bedside monitor itself and the VSM 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.g., at a central station). Secondary remote viewing and alarming features are intended to supplement and not replace patient bedside monitoring. The optional Masimo Rainbow SET Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO 2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SETO 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 P1 is based on four parameters provided by the monitor: end tidal carton dioxide, respiration rate, oxygen saturation and pulse rate. The IP1 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. [P1 monitoring displays a single value that represents the patient's pulmonary parameters and sledts clinicians to changes in the patient's pulmonary status. The P1 is an adjunct to, and is not intended to replace, vital sign monitoring. Optional compatible weight scales (e.g., Health a meters) 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. This product is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K121013
Methodology: https://510kreport.com/methodology