Cleared Traditional

K180734 - SmartLinx Vitals Plus Patient Monitoring System

K180734 is an FDA 510(k) clearance for SmartLinx Vitals Plus Patient Monitorin..., manufactured by Capsule Technologie. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 141-day FDA review.

K180734 · Capsule Technologie · Cardiovascular device
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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.

View all Capsule Technologie devices

FDA 510(k) Submission Details - K180734

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
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
16d slower than avg
Panel avg: 125d · This submission: 141d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

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 253
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K180734.
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Philips Hemodynamic Application R1.0
K181311 · Philips Medical Systems Nederlands B.V. · Sep 2018
VTRUST Vital Signs Monitor, Model: TD-2300
K172221 · Taidoc Technology Corporation · Jun 2018
STAR 65
K172147 · Skanray Technologies Pvt, Ltd. · May 2018
PeraServer and PeraTrend
K172959 · Perahealth, Inc. · May 2018