Cleared Traditional

K151071 - SmartLinx Vitals Plus Patient Monitorin...

K151071 is an FDA 510(k) clearance for SmartLinx Vitals Plus Patient Monitorin..., manufactured by Capsule Technologie Sas. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 149-day FDA review.

K151071 · Capsule Technologie Sas · Cardiovascular device
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Sep 2015
Decision
149d
Days
Class 2
Risk

K151071 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 Sas (Andover, US). The FDA issued a Cleared decision on September 17, 2015 after a review of 149 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 Sas devices

FDA 510(k) Submission Details - K151071

510(k) Number K151071 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 21, 2015
Decision Date September 17, 2015
Days to Decision 149 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
24d slower than avg
Panel avg: 125d · This submission: 149d
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 152
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K151071.
Masimo Root Monitoring System and Accessories
K153225 · Masimo Corporation · Jun 2016
Masimo Root Vital Signs Monitoring System and Accessories
K151644 · Masimo Corporation · Feb 2016
Expression MR400 MRI Patient Monitoring System
K152330 · Invivo Corporation · Dec 2015
740 SELECT
K150620 · Cas Medical Systems, Inc. · May 2015
Unity Network ID
K142840 · Ge Healthcare · Jan 2015
Connex Spot Monitor,901058 Vital Signs Monitor Core
K142356 · Welch Allyn, Inc. · Dec 2014