Cleared Traditional

K143372 - AWARE

K143372 is an FDA 510(k) clearance for AWARE, manufactured by Ambient Clinical Analytics. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 128-day FDA review.

K143372 · Ambient Clinical Analytics · Cardiovascular device
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Optimized for regulatory review, auditing and printing
Apr 2015
Decision
128d
Days
Class 2
Risk

K143372 is an FDA 510(k) clearance for the AWARE. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Ambient Clinical Analytics (Rochester, US). The FDA issued a Cleared decision on April 2, 2015 after a review of 128 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 Ambient Clinical Analytics devices

FDA 510(k) Submission Details - K143372

510(k) Number K143372 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 2014
Decision Date April 02, 2015
Days to Decision 128 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
3d slower than avg
Panel avg: 125d · This submission: 128d
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 175
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K143372.
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Unity Network ID
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Connex Spot Monitor,901058 Vital Signs Monitor Core
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Masimo Root Monitoring System and Accesories
K142394 · Masimo Corporation · Nov 2014