Cleared Traditional

K180734 - SmartLinx Vitals Plus Patient Monitoring System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K180734 · Capsule Technologie · Cardiovascular device
Aug 2018
Decision
141d
Days
Class 2
Risk

K180734 is an FDA 510(k) clearance for the SmartLinx Vitals Plus Patient Monitoring System. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Capsule Technologie (Andover, US). The FDA issued a Cleared decision on August 8, 2018 after a review of 141 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

Submission Details

510(k) Number K180734 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 20, 2018
Decision Date August 08, 2018
Days to Decision 141 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Regulatory Context
Review time vs. panel average
1d slower than avg
Panel avg: 140d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 15
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K180734.
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Empatica Health Monitoring Platform
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Welch Allyn Connex® Spot Monitor
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Portrait VSM
K233810 · Ge Medical Systems Information Technologies, Inc. · Apr 2024
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K234130 · Ge Medical Systems Information Technologies, Inc. · Mar 2024