Cleared Special

K132604 - VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM

K132604 is an FDA 510(k) clearance for VITAL SYNC INFORMATICS MANAGER & VIRTUA..., manufactured by Covidien. The device is a Class 2 Cardiovascular device with product code MWI cleared through the Special 510(k) pathway after a 106-day FDA review.

K132604 · Covidien · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Dec 2013
Decision
106d
Days
Class 2
Risk

K132604 is an FDA 510(k) clearance for the VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Covidien (Boulder, US). The FDA issued a Cleared decision on December 4, 2013 after a review of 106 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - the FDA cardiovascular device oversight framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Standard predicate reliance. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

FDA 510(k) Submission Details - K132604

510(k) Number K132604 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 20, 2013
Decision Date December 04, 2013
Days to Decision 106 days
Submission Type Special
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
19d faster than avg
Panel avg: 125d · This submission: 106d
Pathway characteristics
Modification to existing cleared device.

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 308
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K132604.
VISI MOBILE MONITIORING SYSTEM
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K131497 · Mckesson Israel , Ltd. · Dec 2013
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K132033 · Noblitt & Rueland · Dec 2013
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · Welch Allyn, Inc. · Nov 2013
VISI MOBILE MONITORING SYSTEM
K130709 · Sotera Wireless, Inc. · Oct 2013
PATIENT MONITOR
K123711 · Shenzhen Creative Industry Co., Ltd. · Oct 2013
K132604 · VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
Download PDF FDA Summary Covidien