Cleared Special

K110516 - CONNEX VITAL SIGNS MONITOR 6000 SERIES

K110516 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 98-day FDA review.

K110516 · Welch Allyn, Inc. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Jun 2011
Decision
98d
Days
Class 2
Risk

K110516 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 June 1, 2011 after a review of 98 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 - K110516

510(k) Number K110516 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 23, 2011
Decision Date June 01, 2011
Days to Decision 98 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
27d faster than avg
Panel avg: 125d · This submission: 98d
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 K110516.
OMNI PATIENT MONITOR
K112329 · Infinium Medical · Sep 2011
AIRSTRIP REMOTE PATIENT MONITORING (RPM) REMOTE DATA VIEWING
K112235 · Airstrip Technologies, LP · Aug 2011
OMNI II PATIENT MONITOR
K103737 · Infinium Medical · Jun 2011
DANMEDICAL ANALYSIS SYSTEM, MODEL D-MAS
K100424 · Danmedical Limited · Mar 2011
STAR 50 N
K103686 · Larsen & Toubro Limited · Mar 2011
STELLAR 300
K103763 · Larsen & Toubro Limited · Mar 2011
K110516 · CONNEX VITAL SIGNS MONITOR 6000 SERIES
Download PDF FDA Summary Welch Allyn, Inc.