# K101445: Vital Signs Monitor-VSM 6000 Series

- Pathway: 510(k) (Abbreviated)
- Applicant: Welch Allyn, Inc.
- Decided: Jun 8, 2010 after 15 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: 9 generations back to K962603 (1997). 19 ancestors in all.
73 later devices descend from it; 3 cite it directly.
0 of 93 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K063419: Modification to VSM- Vital Signs Monitor, (VSM 300 ), Welch Allyn Protocol, Inc. (2006) Summary page 1.
- K093907: Welch Allyn Non Invasive Blood Pressure (Nibp) Device, Welch Allyn, Inc. (2010) Summary page 1.
- K040490: Welch Allyn Spot Ultra Vital Signs Device, Welch Allyn, Inc. (2004) Summary page 1.

## Most influential descendants
- K110516: Connex Vital Signs Monitor 6000 Series (2011), 67 descendants of its own
- 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

## Indications for use
The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital, and alternate care environments. This product is available for sale only upon the order of a physician or licensed health care professional.

Source page: https://510kreport.com/device/K101445
Methodology: https://510kreport.com/methodology