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Welch Allyn Inc

FDA Regulatory Profile

Summary

Total Recalls
5
510(k) Clearances
112
Inspections
7
Compliance Actions
0

Recent Recalls

NumberClassProductDate
Z-2482-2021Class IIBraun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body tJuly 20, 2021
Z-1673-2021Class IIProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XApril 22, 2021
Z-1672-2021Class IIGS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intendedApril 22, 2021
Z-1777-2017Class IIWelch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- DFebruary 27, 2017
Z-0169-2016Class IIWelch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78xOctober 2, 2015

Recent 510(k) Clearances

K-NumberDeviceDate
K243598Welch Allyn Connex® 360 (Multiple)July 13, 2025
K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)December 20, 2024
K223381iExaminer System with Panoptic PlusMarch 15, 2023
K212473Welch Allyn Connex Central StationOctober 28, 2022
K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionSeptember 10, 2019
K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemJuly 16, 2018
K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital SignJune 30, 2017
K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreDecember 19, 2014
K141582CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTIONJuly 11, 2014
K132807MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)January 31, 2014
K132808VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITORNovember 20, 2013
K131573CP150 ELECTROCARDIOGRAPHJuly 3, 2013
K121405PANOPTICDecember 20, 2012
K122058FLEXIPORT ECOCUFFNovember 5, 2012
K121013CONNEX VITAL SIGNS MONITOR 6000 SERIESJuly 26, 2012
K120774ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUIApril 10, 2012
K120743SPECULUM, VAGINAL, NONMETALMarch 23, 2012
K120343CONNEX WORKSTATIONFebruary 24, 2012
K112687CONNEX(R) VITAL SIGNS MONITOR 6000 SERIESNovember 22, 2011
K110516CONNEX VITAL SIGNS MONITOR 6000 SERIESJune 1, 2011