Medical Device Manufacturer · US , Mchenry , IL

Welch Allyn, Inc.

111 submissions · 111 cleared · Since 1977
111
Total
111
Cleared
0
Denied

Welch Allyn, Inc. — FDA 510(k) Submissions

Welch Allyn, Inc. has submitted 111 FDA 510(k) premarket notifications since 1977, of which 111 received clearance as substantially equivalent to a predicate device.

The company's most frequent device categories include Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms), System, Measurement, Blood-pressure, Non-invasive, Otoscope, Device, Medical Examination, Ac Powered, Ophthalmoscope, Ac-powered . Use the specialty filter in the sidebar to narrow results.

111 devices
1–25 of 111
Welch Allyn Connex? 360 (Multiple)
K243598 · Cardiovascular
Jul 2025 234d
Welch Allyn Connex? Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
K241411 · MWI Monitor, Physiological,... · Cardiovascular
Dec 2024 217d
iExaminer System with Panoptic Plus
K223381 · HKI Camera, Ophthalmic,... · Ophthalmic
Mar 2023 128d
Welch Allyn Connex Central Station
K212473 · MWI Monitor, Physiological,... · Cardiovascular
Oct 2022 448d
Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
K191013 · BZG Spirometer, Diagnostic · Anesthesiology
Sep 2019 146d
Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
K181016 · NFJ System, Image Management,... · Ophthalmic
Jul 2018 90d
Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
K171621 · MHX Monitor, Physiological,... · Cardiovascular
Jun 2017 28d
Connex Spot Monitor,901058 Vital Signs Monitor Core
K142356 · MWI Monitor, Physiological,... · Cardiovascular
Dec 2014 116d
MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
K132807 · MWI Monitor, Physiological,... · Cardiovascular
Jan 2014 144d
VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
K132808 · MWI Monitor, Physiological,... · Cardiovascular
Nov 2013 70d
CP150 ELECTROCARDIOGRAPH
K131573 · DPS Electrocardiograph · Cardiovascular
Jul 2013 34d
PANOPTIC
K121405 · HKI Camera, Ophthalmic,... · Ophthalmic
Dec 2012 224d
FLEXIPORT ECOCUFF
K122058 · DXQ Blood Pressure Cuff · Cardiovascular
Nov 2012 115d
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K121013 · MWI Monitor, Physiological,... · Cardiovascular
Jul 2012 114d
ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
K120774 · DSI Detector And Alarm,... · Cardiovascular
Apr 2012 27d
SPECULUM, VAGINAL, NONMETAL
K120743 · HIB Speculum, Vaginal, Nonmetal · Obstetrics & Gynecology
Mar 2012 11d
CONNEX WORKSTATION
K120343 · MWI Monitor, Physiological,... · Cardiovascular
Feb 2012 21d
CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
K112687 · MWI Monitor, Physiological,... · Cardiovascular
Nov 2011 68d
CONNEX VITAL SIGNS MONITOR 6000 SERIES
K110516 · MWI Monitor, Physiological,... · Cardiovascular
Jun 2011 98d
WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
K101680 · DXN System, Measurement,... · Cardiovascular
Jul 2010 24d
VITAL SIGNS MONITOR-VSM 6000 SERIES
K101445 · MWI Monitor, Physiological,... · Cardiovascular
Jun 2010 15d
WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
K093907 · DXN System, Measurement,... · Cardiovascular
Apr 2010 113d
WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
K082478 · BZG Spirometer, Diagnostic · Anesthesiology
Mar 2009 193d
WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
K070060 · DXQ Blood Pressure Cuff · Cardiovascular
Dec 2007 347d
CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
K072449 · DPS Electrocardiograph · Cardiovascular
Nov 2007 90d

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