Cleared Special

K121013 - CONNEX VITAL SIGNS MONITOR 6000 SERIES

K121013 is an FDA 510(k) clearance for CONNEX VITAL SIGNS MONITOR 6000 SERIES, manufactured by Welch Allyn, Inc.. The device is a Class 2 Cardiovascular device with 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) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K121013

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.

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 307
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K121013.
COMEN MULTI-PARAMETER PATIENT MONITOR
K112877 · Goldway Us, Inc. · Nov 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K122133 · Airstrip Technologies, LP · Oct 2012
VISI MOBILE MONITORING SYSTEM
K122036 · Sotera Wireless, Inc. · Aug 2012
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K121871 · Airstrip Technologies, LP · Jul 2012
ANY VIEW PATIENT MONITORS
K120193 · Guangdong Biolight Meditech Co., Ltd. · Jun 2012
DATACAPTOR SYSTEM
K113835 · Capsule Tech, Inc. · Jun 2012
K121013 · CONNEX VITAL SIGNS MONITOR 6000 SERIES
Download PDF FDA Summary Welch Allyn, Inc.