Company · US
Welch Allyn, Inc.
FDA 510(k) clearances and medical device recalls filed under this name, 1977 to 2025. Name variants (Inc, Corp, punctuation) are merged.
112510(k) clearances (0 in 12 months)
17recalls (0 in 12 months)
4recalls that name a 510(k)
Product codes
| Code | Device | Records |
|---|---|---|
| DXN | System, Measurement, Blood-Pressure, Non-Invasive | 15 |
| DXQ | Blood Pressure Cuff | 15 |
| MWI | Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | 12 |
| ERA | Otoscope | 9 |
| KZF | Device, Medical Examination, Ac Powered | 6 |
| HLI | Ophthalmoscope, Ac-Powered | 5 |
| BZG | Spirometer, Diagnostic | 4 |
| DPS | Electrocardiograph | 4 |
| FAM | Sigmoidoscope And Accessories, Flexible/Rigid | 4 |
| HIB | Speculum, Vaginal, Nonmetal | 4 |
| DQA | Oximeter | 3 |
| FLL | Continuous Measurement Thermometer | 3 |
| DSI | Detector And Alarm, Arrhythmia | 2 |
| FCW | Light Source, Fiberoptic, Routine | 2 |
| FER | Anoscope And Accessories | 2 |
| FSR | Light, Headband, Surgical | 2 |
| GCT | Light Source, Endoscope, Xenon Arc | 2 |
| HEX | Colposcope (And Colpomicroscope) | 2 |
| HKI | Camera, Ophthalmic, Ac-Powered | 2 |
| KAI | Mirror, Ent | 2 |
Latest 510(k) clearances
| Decided | 510(k) | Device and applicant | Code |
|---|---|---|---|
| Jul 13, 2025 | K243598 | Welch Allyn Connex® 360 (Multiple) Welch Allyn, Inc. | |
| Dec 20, 2024 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) Welch Allyn, Inc. | MWI |
| Mar 15, 2023 | K223381 | iExaminer System with Panoptic Plus Welch Allyn, Inc. | HKI |
| Oct 28, 2022 | K212473 | Welch Allyn Connex Central Station Welch Allyn, Inc. | MWI |
| Sep 10, 2019 | K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option Welch Allyn, Inc. | BZG |
| Jul 16, 2018 | K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System Welch Allyn, Inc. | NFJ |
| Jun 30, 2017 | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor Welch Allyn, Inc. | MHX |
| Dec 19, 2014 | K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core Welch Allyn, Inc. | MWI |
| Jul 11, 2014 | K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION Welch Allyn | DPS |
| Jan 31, 2014 | K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) Welch Allyn, Inc. | MWI |
| Nov 20, 2013 | K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR Welch Allyn, Inc. | MWI |
| Jul 3, 2013 | K131573 | CP150 ELECTROCARDIOGRAPH Welch Allyn, Inc. | DPS |
| Dec 20, 2012 | K121405 | PANOPTIC Welch Allyn, Inc. | HKI |
| Nov 5, 2012 | K122058 | FLEXIPORT ECOCUFF Welch Allyn, Inc. | DXQ |
| Jul 26, 2012 | K121013 | CONNEX VITAL SIGNS MONITOR 6000 SERIES Welch Allyn, Inc. | MWI |
| Apr 10, 2012 | K120774 | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT Welch Allyn, Inc. | DSI |
| Mar 23, 2012 | K120743 | SPECULUM, VAGINAL, NONMETAL Welch Allyn, Inc. | HIB |
| Feb 24, 2012 | K120343 | CONNEX WORKSTATION Welch Allyn, Inc. | MWI |
| Nov 22, 2011 | K112687 | CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES Welch Allyn, Inc. | MWI |
| Jun 1, 2011 | K110516 | CONNEX VITAL SIGNS MONITOR 6000 SERIES Welch Allyn, Inc. | MWI |
| Jul 9, 2010 | K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES Welch Allyn, Inc. | DXN |
| Jun 8, 2010 | K101445 | VITAL SIGNS MONITOR-VSM 6000 SERIES Welch Allyn, Inc. | MWI |
| Apr 14, 2010 | K093907 | WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE Welch Allyn, Inc. | DXN |
| Mar 9, 2009 | K082478 | WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 Welch Allyn, Inc. | BZG |
| Dec 18, 2007 | K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) Welch Allyn, Inc. | DXQ |
| Nov 29, 2007 | K072449 | CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS Welch Allyn, Inc. | DPS |
| Jun 14, 2007 | K071218 | PROXENON 350, MODEL 902XX Welch Allyn, Inc. | FST |
| May 18, 2007 | K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM Welch Allyn, Inc. | HIB |
| Jun 15, 2006 | K053381 | WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE Welch Allyn, Inc. | DQA |
| Dec 16, 2005 | K052160 | ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) Welch Allyn, Inc. | DSI |
| Nov 22, 2005 | K053027 | VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) Welch Allyn, Inc. | MWI |
| Nov 22, 2005 | K052784 | DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 Welch Allyn, Inc. | DXN |
| Sep 8, 2005 | K052158 | WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE Welch Allyn, Inc. | BZG |
| Mar 22, 2005 | K050074 | 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 Welch Allyn, Inc. | DPS |
| Sep 14, 2004 | K040479 | PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 Welch Allyn, Inc. | MKJ |
| Aug 18, 2004 | K040490 | WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE Welch Allyn, Inc. | DXN |
| Mar 12, 2004 | K033870 | IMAGE MANAGEMENT SYSTEM Welch Allyn, Inc. | HEX |
| Aug 11, 2003 | K031549 | SOLID STATE LAMP [LED] HEADLIGHT Welch Allyn, Inc. | FSR |
| Aug 11, 2003 | K031548 | LED HEADLIGHT Welch Allyn, Inc. | FSR |
| May 6, 2003 | K030580 | SURETEMP PLUS Welch Allyn, Inc. | FLL |
| Feb 12, 2003 | K024005 | WELCH ALLYN VITAL SIGN MONITOR WITH MP506 Welch Allyn, Inc. | DXN |
| Oct 31, 2002 | K023495 | WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) Welch Allyn, Inc. | DXN |
| Sep 26, 2002 | K022084 | ATLAS MONITOR, MODELS 200,210,220 Welch Allyn, Inc. | DQA |
| Sep 17, 2002 | K022163 | WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 Welch Allyn, Inc. | DQA |
| Jun 27, 2002 | K021756 | WELCH ALLYN ABPM 6100 Welch Allyn, Inc. | DXN |
| Aug 17, 2001 | K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM Welch Allyn, Inc. | DXQ |
| Jun 8, 2001 | K010186 | WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM Welch Allyn, Inc. | DXN |
| Jan 29, 2001 | K001543 | BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 Welch Allyn, Inc. | DXN |
| Jan 25, 2001 | K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE Welch Allyn, Inc. | HLI |
| Nov 14, 2000 | K002530 | WELCH ALLYN SPOT CHECK DEVICE Welch Allyn, Inc. | DXN |
Newest 50 of 112.
Latest recalls
| Date | Firm and product | Code | Linked 510(k) |
|---|---|---|---|
| Jul 20, 2021 | Welch Allyn Inc 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 adul Open, Classified |
FLL | K152748 |
| Apr 22, 2021 | Welch Allyn Inc 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 neonate Terminated |
DXN | K101680 |
| Apr 22, 2021 | Welch Allyn Inc GS777 Wall Transformer
Model: 77710
Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings. Terminated |
DXN | None listed |
| Feb 27, 2017 | Welch Allyn Inc 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 Co Terminated |
DXN | K152770 |
| Oct 30, 2015 | Welch Allyn Inc 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, 78 Terminated |
HIB | K120743 |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-2, 5082-105-2CL, and so Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 5 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-105-1 and sold as part of a mu Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-2, 5082-104-2CL, and so Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-104-1 and sold as part of a mu Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-2, 5082-102-2CL , and so Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 3 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-103-1 and sold as part of a mu Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-2, 5082-102-2CL, 671-50 Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 2 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part # 5082-102-1 and sold as part of a mu Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 2 TUBES, a disposable 1 piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' label with Part #s 5082-101-2, 5082-101-2CL, and s Terminated |
DXQ | None listed |
| Jul 20, 2004 | Welch Allyn Inc NEONATE 1 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable 1 piece cuff for single patient use only. Sold under the Welch Allyn label with Part #5082-101-1, and sold as part of a multi-pack ( Terminated |
DXQ | None listed |
| Jan 16, 2004 | Welch Allyn Inc Sure Temp Plus Model 690/692 Oral Temperature Probes Terminated |
FLL | None listed |
| Dec 18, 2003 | Welch Allyn Inc NEONATE 4 DISPOSABLE BLOOD PRESSURE CUFF WITH 1 TUBE, a disposable one piece cuff, for single patient use only. Sold under the Welch Allyn ''Tycos'' and Allegiance ''Tactics'' labels. The ''4'' rep Terminated |
DXQ | None listed |