# K110516: Connex Vital Signs Monitor 6000 Series

- Pathway: 510(k) (Special)
- Applicant: Welch Allyn, Inc.
- Decided: Jun 1, 2011 after 98 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: 13 generations back to K962603 (1997). 58 ancestors in all.
67 later devices descend from it; 1 cites it directly.
1 of 126 devices in its family (counting itself) has a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K101445: Vital Signs Monitor-VSM 6000 Series, Welch Allyn, Inc. (2010) Summary page 1.
- K080238: Masimo Rainbow Set Radical 7 Pulse CO-Oximeter, Masimo Rainbow Set Rad 87 Pulse CO-Oximeter, Masimo Corporation (2008) Summary page 1.
- K100428: Masimo Rainbow Set Radical 7R Pulse CO-Oximeter, Masimo Corporation (2010) Summary page 1.
- (no number) Patient scales marketed pursuant to 21 CFR 880.2700 and 880.2720, Class I, 510(k) exempt (e.g. Health o meter): named in the summary without a submission number

## Most influential descendants
- K112687: Connex (R) Vital Signs Monitor 6000 Series (2011), 66 descendants of its own
- K121013: Connex Vital Signs Monitor 6000 Series (2012), 65 descendants of its own
- 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

## 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 (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® and accessories are indicated for the continuous noninvasive monitoring of total hemoglobin concentration of 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. Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input. This product is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K110516
Methodology: https://510kreport.com/methodology