Cleared Traditional

K120631 - PATIENT MONITOR

K120631 is an FDA 510(k) clearance for PATIENT MONITOR, manufactured by Advanced Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K120631 · Advanced Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
May 2012
Decision
85d
Days
Class 2
Risk

K120631 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 Instruments, Inc. (Hialeah, US). The FDA issued a Cleared decision on May 25, 2012 after a review of 85 days - a notably fast clearance 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: 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 Advanced Instruments, Inc. devices

FDA 510(k) Submission Details - K120631

510(k) Number K120631 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 01, 2012
Decision Date May 25, 2012
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MHX Device Classification - Class 2, Special Controls

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 332
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K120631.
INTELLIVUE PATIENT MONITOR
K122439 · Philips Medizin Systeme Boeblingen GmbH · Aug 2012
INTELLIVUE PATIENT MONITOR
K120366 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jul 2012
ZOLL PROPAQ XM
K121367 · ZOLL Medical Corporation · Jun 2012
PATIENT MONITOR
K120173 · Edan Instruments, Inc. · May 2012
SPACELABS HEALTHCARE QUBE COMPACT MONITOR (91390
K120616 · Spacelabs Medical, Inc. · Mar 2012
PHYSIOLOGICAL MONITOR, PATIENT MONITOR
K113441 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Mar 2012