# K151071: SmartLinx Vitals Plus Patient Monitoring System

- Pathway: 510(k) (Traditional)
- Applicant: Capsule Technologie Sas
- Decided: Sep 17, 2015 after 149 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: 8 generations back to K962603 (1997). 42 ancestors in all.
3 later devices descend from it; 1 cites it directly.
2 of 46 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102426: Carescape Model V100 Vital Signs Monitor, Ge Medical Systems Information Technologies (2010) Summary page 4.

## Most influential descendants
- K171751: SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module (2017), 2 descendants of its own
- K190468: Nihon Kohden SVM-7200 Series Vital Signs Monitor (2019), 0 descendants of its own
- K180734: SmartLinx Vitals Plus Patient Monitoring System (2018), 0 descendants of its own

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

Source page: https://510kreport.com/device/K151071
Methodology: https://510kreport.com/methodology