Cleared Traditional

K131497 - MCKESSON CARDIOLOGY HEMO

K131497 is an FDA 510(k) clearance for MCKESSON CARDIOLOGY HEMO, manufactured by Mckesson Israel , Ltd.. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Traditional 510(k) pathway after a 195-day FDA review.

K131497 · Mckesson Israel , Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
195d
Days
Class 2
Risk

K131497 is an FDA 510(k) clearance for the MCKESSON CARDIOLOGY HEMO. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Mckesson Israel , Ltd. (Alpharetta, US). The FDA issued a Cleared decision on December 5, 2013 after a review of 195 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 Mckesson Israel , Ltd. devices

FDA 510(k) Submission Details - K131497

510(k) Number K131497 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 24, 2013
Decision Date December 05, 2013
Days to Decision 195 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
70d slower than avg
Panel avg: 125d · This submission: 195d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

MWI Device Classification - Class 2, Special Controls

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 175
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K131497.
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K140339 · Covidien · Apr 2014
A SERIES AND Q SERIES PATIENT MONITORS
K131898 · Guangdong Biolight Meditech Co., Ltd. · Feb 2014
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
K132807 · Welch Allyn, Inc. · Jan 2014
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K132604 · Covidien · Dec 2013
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · Welch Allyn, Inc. · Nov 2013
MRI PATIENT MONITORING SYSTEM
K132359 · Invivo Corporation · Aug 2013