# K051375: Vital Signs Monitor

- Pathway: 510(k) (Traditional)
- Applicant: Mediana Co., Ltd.
- Decided: Jul 28, 2005 after 63 days
- Product code: DXN (System, Measurement, Blood-Pressure, Non-Invasive)
- Device class: 2
- Regulation: 21 CFR 870.1130
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 8 generations back to K962603 (1997). 20 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 24 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K031740: VSM - Vital Signs Monitor, Model 53000 Series, Welch Allyn Protocol, Inc. (2003) Summary page 1.
- K033378: Vital Signs Monitor, Propaq LT, Welch Allyn Protocol, Inc. (2004) Summary page 1.
- K021090: Oximax N-550 Pulse Oximeter,Model N-550 Pulse Oximeter, Nellcor Puritan Bennett, Inc. (2002) Summary page 1.
- K024005: Welch Allyn Vital Sign Monitor with MP506, Welch Allyn, Inc. (2003) Summary page 1.

## Most influential descendants
- K152659: V10 (2016), 2 descendants of its own
- K170497: V10 (2017), 1 descendant of its own
- K200434: V20, V20a, AVSM3 SNF (2020), 0 descendants of its own

## Indications for use
The purpose and function of the Mediana ARGUS VCM vital signs monitor is to monitor non-invasive blood pressure (systolic, diastolic, and mean arterial pressures), functional arterial oxygen saturation, pulse rate for adult, pediatric and neonate patients and temperature for adult and pediatric patients in all hospital areas and hospital-type facilities. It may be used during hospital transport and in mobile, land-based environments, such as ambulances, within the specification of the environmental characteristics. Note: Hospital use typically covers such areas as general care floors, operating rooms, special procedure areas, intensive and critical care areas, within the hospital plus hospital-type facilities. Hospital-type facilities include physician office based facilities, sleep labs, skilled nursing facilities, surgicenters, and sub-acutecenters. Note: Intra-hospital transport includes transport of a patient within the hospital or hospital-type facility.

Source page: https://510kreport.com/device/K051375
Methodology: https://510kreport.com/methodology