Cleared Traditional

K143751 - Visi Mobile Monitoring System

K143751 is an FDA 510(k) clearance for Visi Mobile Monitoring System, manufactured by Sotera Wireless, Inc.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 23-day FDA review.

K143751 · Sotera Wireless, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2015
Decision
23d
Days
Class 2
Risk

K143751 is an FDA 510(k) clearance for the Visi Mobile Monitoring System. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Sotera Wireless, Inc. (San Diego, US). The FDA issued a Cleared decision on January 23, 2015 after a review of 23 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Sotera Wireless, Inc. devices

FDA 510(k) Submission Details - K143751

510(k) Number K143751 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 31, 2014
Decision Date January 23, 2015
Days to Decision 23 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Regulatory Context
Review time vs. panel average
102d faster than avg
Panel avg: 125d · This submission: 23d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. Third-party reviewed.

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 160
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K143751.
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
Masimo Root Monitoring System and Accesories
K142394 · Masimo Corporation · Nov 2014