Cleared Traditional

K131223 - CARESCAPE MONITOR B650

K131223 is an FDA 510(k) clearance for CARESCAPE MONITOR B650, manufactured by GE Healthcare Finland Oy. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 120-day FDA review.

K131223 · GE Healthcare Finland Oy · Cardiovascular device
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Aug 2013
Decision
120d
Days
Class 2
Risk

K131223 is an FDA 510(k) clearance for the CARESCAPE MONITOR B650. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by GE Healthcare Finland Oy (Helsinki, FI). The FDA issued a Cleared decision on August 28, 2013 after a review of 120 days - within the typical 510(k) review window.

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 GE Healthcare Finland Oy devices

FDA 510(k) Submission Details - K131223

510(k) Number K131223 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 30, 2013
Decision Date August 28, 2013
Days to Decision 120 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
5d faster than avg
Panel avg: 125d · This submission: 120d
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 319
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K131223.
CARESCAPE MONITOR B450
K132533 · GE Healthcare Finland Oy · Dec 2013
SURVEYOR CENTRAL STATION
K131929 · Mortara Instrument, Inc. · Dec 2013
INTELLIVUE PATIENT MONITOR MX500, INTELLIVUE PATIENT MONITOR MX550
K131872 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Oct 2013
CARESCAPE MONITOR B850
K131414 · GE Healthcare Finland Oy · Aug 2013
INTELLIVUE PATIENT MONITOR
K131829 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2013
PHILIPS SURESIGNS CENTRAL
K131032 · Philips Medical Systems · Aug 2013