# K210204: Capsule Vitals Plus Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Capsule Technologie Sas
- Decided: Oct 19, 2021 after 266 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: 21 generations back to K962603 (1997). 93 ancestors in all.
No later device cites it as a predicate yet.
2 of 94 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200856: SmartLinx Vitals Plus Patient Monitoring System, Capsule Technologie Sas (2020) Summary page 4.

## Indications for use
The Capsule 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/K210204
Methodology: https://510kreport.com/methodology