# K200856: SmartLinx Vitals Plus Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Capsule Technologie Sas
- Decided: Jul 10, 2020 after 100 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: 20 generations back to K962603 (1997). 92 ancestors in all.
1 later device descends from it; 1 cites it directly.
2 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183638: SmartLinx Vitals Plus Patient Monitoring System, Capsule Technologie (2019) Summary page 4.
- K171121: Masimo Root Monitoring System and Accessories, Masimo Corporation (2017) Summary page 4.

## Most influential descendants
- K210204: Capsule Vitals Plus Patient Monitoring System (2021), 0 descendants of its own

## Indications for use
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

Source page: https://510kreport.com/device/K200856
Methodology: https://510kreport.com/methodology