Cleared Traditional

K130584 - MONITOR B40

K130584 is an FDA 510(k) clearance for MONITOR B40, manufactured by Ge Medical Systems China Co., Ltd.. The device is a Class 2 Cardiovascular device with product code MHX cleared through the Traditional 510(k) pathway after a 113-day FDA review.

K130584 · Ge Medical Systems China Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jun 2013
Decision
113d
Days
Class 2
Risk

K130584 is an FDA 510(k) clearance for the MONITOR B40. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Ge Medical Systems China Co., Ltd. (Milwaukee, US). The FDA issued a Cleared decision on June 26, 2013 after a review of 113 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 Medical Systems China Co., Ltd. devices

FDA 510(k) Submission Details - K130584

510(k) Number K130584 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 05, 2013
Decision Date June 26, 2013
Days to Decision 113 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
12d faster than avg
Panel avg: 125d · This submission: 113d
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 320
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K130584.
INTELLIVUE PATIENT MONITOR
K131829 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Aug 2013
PHILIPS SURESIGNS CENTRAL
K131032 · Philips Medical Systems · Aug 2013
IMEC, IPM AND BENEVIEW T1 PATIENT MONITORS
K123074 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2013
MFM-CMS CENTRAL MONITORING SYSTEM
K120727 · Edan Instruments, Inc. · Jun 2013
INTELLIVUE PATIENT MONITOR MX400
K130849 · Philips Medizinsysteme Boeblingen GmbH, Cardiac AN · Jun 2013
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
K123900 · Philips Medical Systems · Apr 2013