Welch Allyn, Inc.
Welch Allyn, Inc. holds FDA 510(k) medical device clearances, first cleared 1977, most recent 2025, with 5 FDA device recalls on record.
Top product codes for Welch Allyn, Inc.
FDA recalls by Welch Allyn, Inc.
- Z-2482-2021 — Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patients having ages ranging from normal weight (full term) newborn to geriatric adults in a professional use environment. Model: 6000
- Z-1672-2021 — GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings.
- Z-1673-2021 — ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: ProBP 3400 automatically measures systolic and diastolic pressure (excluding neonates) and pulse rate, as well as calculates Mean Arterial Pressure (MAP).
- Z-1777-2017 — Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- Distributed by Welch Allyn Inc., 4341 State Street Road, Skaneateles Falls, NY 13153 --- Microlife Corporation 9F, 431, RuiGuang Road, NeiHu, Taipei, 11492, Taiwan, R.O.C. --- Microlife AG Espenstrasse 139 9443 Widnau, Switzerland
- Z-0169-2016 — Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x Series Illuminator, REF 901070, Catalog Numbers 78800, 73410, 73412, 73414, 73416, 78810, 78812, 78814 and 78816, Rx ONLY
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Welch Allyn, Inc.
1–100 of 111- K243598 — Welch Allyn Connex® 360 (Multiple)
- K241411 — Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)
- K223381 — iExaminer System with Panoptic Plus
- K212473 — Welch Allyn Connex Central Station
- K191013 — Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option
- K181016 — Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System
- K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor
- K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core
- K132807 — MONITORING STATION, CONNEX(R) CENTRAL STATION (CS)
- K132808 — VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
- K131573 — CP150 ELECTROCARDIOGRAPH
- K121405 — PANOPTIC
- K122058 — FLEXIPORT ECOCUFF
- K121013 — CONNEX VITAL SIGNS MONITOR 6000 SERIES
- K120774 — ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT
- K120743 — SPECULUM, VAGINAL, NONMETAL
- K120343 — CONNEX WORKSTATION
- K112687 — CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES
- K110516 — CONNEX VITAL SIGNS MONITOR 6000 SERIES
- K101680 — WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES
- K101445 — VITAL SIGNS MONITOR-VSM 6000 SERIES
- K093907 — WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE
- K082478 — WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62
- K070060 — WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE)
- K072449 — CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS
- K071218 — PROXENON 350, MODEL 902XX
- K070964 — KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM
- K053381 — WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE
- K052160 — ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.)
- K052784 — DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900
- K053027 — VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300)
- K052158 — WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE
- K050074 — 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200
- K040479 — PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20
- K040490 — WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE
- K033870 — IMAGE MANAGEMENT SYSTEM
- K031548 — LED HEADLIGHT
- K031549 — SOLID STATE LAMP [LED] HEADLIGHT
- K030580 — SURETEMP PLUS
- K024005 — WELCH ALLYN VITAL SIGN MONITOR WITH MP506
- K023495 — WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK)
- K022084 — ATLAS MONITOR, MODELS 200,210,220
- K022163 — WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506
- K021756 — WELCH ALLYN ABPM 6100
- K012455 — WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM
- K010186 — WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM
- K001543 — BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520
- K003376 — WELCH ALLYN 11800 OPTHALMOSCOPE
- K002530 — WELCH ALLYN SPOT CHECK DEVICE
- K001265 — WELCH ALLYN INSTRUMENT INTERFACE MODULE
- K984033 — ATLAS MONITOR
- K984215 — WELCH ALLYN FRONT-LINE DOC
- K981937 — WELCH ALLYN REVEAL INTRAORAL CAMERA SYSTEM
- K980281 — WELCH ALLYN XENON 300 LIGHT SOURCE
- K971734 — VG 200 VIDEO GASTROSCOPE
- K971750 — WELCH ALLYN PHACO ILLUMINATOR
- K970382 — VS-100 VIDEO SIGMOIDOSCOPE
- K955635 — VIDEO COLPOSCOPE/VERTICAL ROLLING BASE/SWING ARM STAND
- K954704 — VS-200 VIDEO SIGMOIDOSCOPE
- K955043 — WELCH ALLYN BI-OTOSCOPE
- K952835 — WELCH ALLYN VIDEO EPISCOPE
- K950429 — VIDEO SIGMOIDOSCOPE
- K952691 — WELCH ALLYN PREMIUM LIGHTWEIGHT HEADLIGHT
- K952289 — WELCH ALLYN FIBER OPTIC HEADLIGNT
- K952578 — WELCH ALLY OTOSCOPE
- K951210 — WELCH ALLYN VIDEO OPHTHALMOSCOPE
- K951647 — WELCH ALLYN HI - LUX ILLUMINATOR
- K950787 — WELCH ALLYN OTOSCOPE
- K950461 — WELCH ALLYN OPHTHALMOSCOPE
- K943916 — VIDEOTOSCOPE
- K941272 — KLEENSPEC
- K940493 — HAND ANEROID SPHYGMOMANOMETER
- K941723 — WELCH ALLYN GLAUCOMA DETECTOR
- K940270 — LCI-100 AND LCI-200 WELCH ALLYN ILLUMINATION AND IMAGING SYSTEM
- K934259 — AC-POWERED MEDICAL EXAMINATION LIGHT
- K931946 — WELCH ALLYN EARCLEANER
- K930023 — MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE
- K925899 — AMBULATORY BLOOD PRESSURE MONITOR, MDL# 5100-01
- K921493 — LS100 HALOGEN EXAMINATION LIGHT, MODEL NO: 44100
- K922095 — LX 150 LIGHT SOURCE
- K920103 — EPISCOPE, MODEL 47300
- K913230 — UNIDIRECTIONAL OCCLUDER
- K895253 — PNEUMOCHECK W/PRINTER/CHARGER AND ACCESSORIES
- K893440 — FLEX SIGMOIDOSCOPE LIGHT SOURCE MODEL #45150
- K884218 — AUDIOSCOPE 3 MODEL 23300 ACCESSORIES
- K875194 — KLEENSPEC DISPOSABLE FACE SHIELD, MODEL 57001
- K861516 — WELCH ALLYN TYMPANOMETER
- K852574 — WELCH ALLYN MODEL 40000 SPHYG W/ 40030-35 BLAD & C
- K852949 — WELCH ALLYN #48100 TASK LITE W/ACCESSORIES AS LIST
- K852951 — WELCH ALLYN FIBER OPTIC CABLES VARIOUS MODELS
- K831709 — AUDIOSCOPE #23000 W/71123 CHARGING STAND
- K830047 — FIBER OPTIC LARYNGOSCOPES W/BATTERY
- K822125 — MODEL 57000 NASO-CONJUNCTIVA ISOL. MASK
- K810227 — MODEL #53110 DISPOSABLE ANOSCOPE
- K801247 — CCD ENDOSCOPE AND ATTACHMENTS
- K790610 — SIGMOIDOSCOPE TIPLESS
- K782142 — ILLIMINATOR, MODEL 265 NASAL
- K781517 — AUTOMATIC BLOOD PRESSURE DEVICE
- K781029 — OTOSCOPE, DIAG. MODELS 20100 & 20200
- K780628 — HALOGEN EXAM. LITE #48400
Data sourced from openFDA. This site is unofficial and independent of the FDA.