Cleared Special

K121013 - CONNEX VITAL SIGNS MONITOR 6000 SERIES

K121013 is the FDA 510(k) clearance for CONNEX VITAL SIGNS MONITOR 6000 SERIES by Welch Allyn, Inc.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Special 510(k) pathway after a 114-day FDA review.

K121013 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2012
Decision
114d
Days
Class 2
Risk

K121013 is an FDA 510(k) clearance for the CONNEX VITAL SIGNS MONITOR 6000 SERIES. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on July 26, 2012 after a review of 114 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.

View all Welch Allyn, Inc. devices

Submission Details

510(k) Number K121013 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 03, 2012
Decision Date July 26, 2012
Days to Decision 114 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
11d faster than avg
Panel avg: 125d · This submission: 114d
Pathway characteristics
Modification to existing cleared device.

Device Classification

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 123
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K121013.
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VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · Welch Allyn, Inc. · Nov 2013
VITAL SYNC INFORMATICS MANAGER & VIRTUAL PATIENT MONITORING PLATFORM
K130796 · Covidien · May 2013
CONNEX WORKSTATION
K120343 · Welch Allyn, Inc. · Feb 2012
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
K112687 · Welch Allyn, Inc. · Nov 2011
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K110516 · Welch Allyn, Inc. · Jun 2011