Cleared Traditional

K132077 - PATIENT MONITOR

K132077 is the FDA 510(k) clearance for PATIENT MONITOR by Advanced Instrumentations, Inc.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 292-day FDA review.

K132077 · Advanced Instrumentations, Inc. · Cardiovascular device
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Apr 2014
Decision
292d
Days
Class 2
Risk

K132077 is an FDA 510(k) clearance for the PATIENT MONITOR. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Advanced Instrumentations, Inc. (Hialeah, US). The FDA issued a Cleared decision on April 23, 2014 after a review of 292 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 Advanced Instrumentations, Inc. devices

Submission Details

510(k) Number K132077 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 05, 2013
Decision Date April 23, 2014
Days to Decision 292 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
167d slower than avg
Panel avg: 125d · This submission: 292d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 287
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K132077.
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K150030 · Fukuda Denshi USA, Inc. · Mar 2015
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MORTARA MONITORING WAVEFORM VIEWER
K141811 · Mortara Instrument, Inc. · Nov 2014
IM60/IM70 PATIENT MONITOR
K131971 · Edan Instruments, Inc. · Mar 2014
SURVEYOR CENTRAL STATION
K131929 · Mortara Instrument, Inc. · Dec 2013
PHILIPS SURESIGNS CENTRAL
K131032 · Philips Medical Systems · Aug 2013