Cleared Traditional

K131032 - PHILIPS SURESIGNS CENTRAL

K131032 is the FDA 510(k) clearance for PHILIPS SURESIGNS CENTRAL by Philips Medical Systems. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K131032 · Philips Medical Systems · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2013
Decision
122d
Days
Class 2
Risk

K131032 is an FDA 510(k) clearance for the PHILIPS SURESIGNS CENTRAL. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Philips Medical Systems (Andover, US). The FDA issued a Cleared decision on August 12, 2013 after a review of 122 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 Philips Medical Systems devices

Submission Details

510(k) Number K131032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 12, 2013
Decision Date August 12, 2013
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 207
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K131032.
Fukuda Denshi DynaScope Model DS-8000 Series Patient Monitor
K150030 · Fukuda Denshi USA, Inc. · Mar 2015
FUKUDA DENSHI DYNASCOPE MODEL DS-8100N/8100M PATIENT MONITOR
K134046 · Fukuda Denshi USA, Inc. · Feb 2015
IM60/IM70 PATIENT MONITOR
K131971 · Edan Instruments, Inc. · Mar 2014
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
SURESIGNS VM4, SURESIGNS VM6, SURESIGNS VM8
K123900 · Philips Medical Systems · Apr 2013