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SmartLinx Vitals Plus Patient Monitoring System

by Capsule Technologie 2 variants

510(k) K183638

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK183638 Date17 Apr 2019ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
MWI
Device Class
Class II
Regulation
21 CFR Part 870.2300
Advisory Committee
Cardiovascular
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The SmartLinx Vitals Plus Patient Monitoring System is a medical device classified as a Patient Monitoring System (Product Code MWI) designed to continuously monitor and alarm physiologic parameters. It measures non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO₂), and temperature across adult, pediatric, and neonatal patients.

This system is intended for use in non-critical care hospital settings, providing integrated surveillance of vital signs. Supplied as a reusable device, it requires adherence to standard infection control protocols. Authorized under FDA 510(k) clearance (K183638), it was determined substantially equivalent through the Cardiovascular (CV) advisory committee review.

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