# 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

- Pathway: 510(k) (Traditional)
- Applicant: Capsule Technologie Sas
- Decided: Oct 24, 2017 after 133 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). 56 ancestors in all.
2 later devices descend from it; 2 cite it directly.
2 of 59 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K130411: 740 Select, Cas Medical Systems, Inc. (2013) Summary page 4.
- K151071: SmartLinx Vitals Plus Patient Monitoring System, Capsule Technologie Sas (2015) Summary page 4.

## Most influential descendants
- 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 and alarming of 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 hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.

Source page: https://510kreport.com/device/K171751
Methodology: https://510kreport.com/methodology