Welch Allyn Inc
Skaneateles Falls, NY, US
WELCH ALLYN, INC. appears in FDA device records in Skaneateles Falls, NY. FDA records list 112 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 17 recalls for this company, and at least one establishment registration is current.
FDA records held for this company
510(k) clearance history
Showing 50 of 112FDA records hold 112 510(k) clearances for Welch Allyn Inc between 1977 and 2025. The busiest year on record is 1977, with 11. The most recent is 2025, with 1.
Clearances by year, as a table
| Year | Clearances |
|---|---|
| 1977 | 11 |
| 1978 | 2 |
| 1979 | 3 |
| 1980 | 1 |
| 1981 | 1 |
| 1982 | 1 |
| 1983 | 2 |
| 1985 | 2 |
| 1986 | 2 |
| 1988 | 1 |
| 1989 | 3 |
| 1991 | 1 |
| 1992 | 3 |
| 1993 | 3 |
| 1994 | 6 |
| 1995 | 10 |
| 1996 | 2 |
| 1997 | 3 |
| 1998 | 2 |
| 1999 | 2 |
| 2000 | 2 |
| 2001 | 4 |
| 2002 | 4 |
| 2003 | 4 |
| 2004 | 3 |
| 2005 | 5 |
| 2006 | 1 |
| 2007 | 4 |
| 2009 | 1 |
| 2010 | 3 |
| 2011 | 2 |
| 2012 | 6 |
| 2013 | 2 |
| 2014 | 3 |
| 2017 | 1 |
| 2018 | 1 |
| 2019 | 1 |
| 2022 | 1 |
| 2023 | 1 |
| 2024 | 1 |
| 2025 | 1 |
| K number | Device | Product code | Decision | Decision date |
|---|---|---|---|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) | Substantially Equivalent | ||
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | MWI | Substantially Equivalent | |
| K223381 | iExaminer System with Panoptic Plus | HKI | Substantially Equivalent | |
| K212473 | Welch Allyn Connex Central Station | MWI | Substantially Equivalent | |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | BZG | Substantially Equivalent | |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | NFJ | Substantially Equivalent | |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | MHX | Substantially Equivalent | |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | MWI | Substantially Equivalent | |
| K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | DPS | Substantially Equivalent | |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | MWI | Substantially Equivalent | |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | MWI | Substantially Equivalent | |
| K131573 | CP150 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | |
| K121405 | PANOPTIC | HKI | Substantially Equivalent | |
| K122058 | FLEXIPORT ECOCUFF | DXQ | Substantially Equivalent | |
| K121013 | CONNEX VITAL SIGNS MONITOR 6000 SERIES | MWI | Substantially Equivalent | |
| K120774 | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUITY, MOBILE LT | DSI | Substantially Equivalent | |
| K120743 | SPECULUM, VAGINAL, NONMETAL | HIB | Substantially Equivalent | |
| K120343 | CONNEX WORKSTATION | MWI | Substantially Equivalent | |
| K112687 | CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES | MWI | Substantially Equivalent | |
| K110516 | CONNEX VITAL SIGNS MONITOR 6000 SERIES | MWI | Substantially Equivalent | |
| K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES | DXN | Substantially Equivalent | |
| K101445 | VITAL SIGNS MONITOR-VSM 6000 SERIES | MWI | Substantially Equivalent | |
| K093907 | WELCH ALLYN NON INVASIVE BLOOD PRESSURE (NIBP) DEVICE | DXN | Substantially Equivalent | |
| K082478 | WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 | BZG | Substantially Equivalent | |
| K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | DXQ | Substantially Equivalent | |
| K072449 | CP100 & 200 12-LEAD RESTING ELECTROCARDIOGRAPHS | DPS | Substantially Equivalent | |
| K071218 | PROXENON 350, MODEL 902XX | FST | Substantially Equivalent | |
| K070964 | KLEENSPEC SINGLE USE VAGINAL SPECULUM AND 790 SERIES CORDLESS ILLUMINATION SYSTEM | HIB | Substantially Equivalent | |
| K053381 | WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE | DQA | Substantially Equivalent | |
| K052160 | ACUITY CENTRAL STATION, MODEL 020XXXXX (NOTE: XXXXX = VARIOUS CONFIG.) | DSI | Substantially Equivalent | |
| K053027 | VSM VITAL SIGNS MONITOR, MODEL 53000 (VSM 300) | MWI | Substantially Equivalent | |
| K052784 | DEVICE CONNECTIVITY SOFTWARE DEVELOPERS KIT (SDK), MODEL 4500-900 | DXN | Substantially Equivalent | |
| K052158 | WELCH ALLYN CARDIOPERFECT WORKSTATION VERSION 1.5.0 SOFTWARE | BZG | Substantially Equivalent | |
| K050074 | 12-LEAD RESTING ELECTROCARDIOGRAPH, MODELS CP100 & CP200 | DPS | Substantially Equivalent | |
| K040479 | PEDIATRIC ENERGY REDUCER, MODELS AED-10 AND AED-20 | MKJ | Substantially Equivalent | |
| K040490 | WELCH ALLYN SPOT ULTRA VITAL SIGNS DEVICE | DXN | Substantially Equivalent | |
| K033870 | IMAGE MANAGEMENT SYSTEM | HEX | Substantially Equivalent | |
| K031549 | SOLID STATE LAMP [LED] HEADLIGHT | FSR | Substantially Equivalent | |
| K031548 | LED HEADLIGHT | FSR | Substantially Equivalent | |
| K030580 | SURETEMP PLUS | FLL | Substantially Equivalent | |
| K024005 | WELCH ALLYN VITAL SIGN MONITOR WITH MP506 | DXN | Substantially Equivalent | |
| K023495 | WELCH ALLYN VITALS SOFTWARE DEVELOPERS KIT (SDK) | DXN | Substantially Equivalent | |
| K022084 | ATLAS MONITOR, MODELS 200,210,220 | DQA | Substantially Equivalent | |
| K022163 | WELCH ALLYN SPOT VITAL SIGN MONITOR WITH MP506 | DQA | Substantially Equivalent | |
| K021756 | WELCH ALLYN ABPM 6100 | DXN | Substantially Equivalent | |
| K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM | DXQ | Substantially Equivalent | |
| K010186 | WELCH ALLYN IMPACT BLOOD PRESSURE SYSTEM | DXN | Substantially Equivalent | |
| K001543 | BPC-3000 PERSONAL BLOOD PRESSURE COMMUNICATOR, MODEL 52520 | DXN | Substantially Equivalent | |
| K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | HLI | Substantially Equivalent | |
| K002530 | WELCH ALLYN SPOT CHECK DEVICE | DXN | Substantially Equivalent |
Registered establishments
| Registration | FEI | Establishment | Address | Registration expires | Product codes listed |
|---|---|---|---|---|---|
| 1316463 | 1316463 | WELCH ALLYN, INC. | 4341 STATE STREET RD., Skaneateles Falls, NY 13153 US | 2026 | and 43 more, listed in full below |
Registration numbers link to the FDA registration and listing record for that establishment.
FDA product codes
- DSJAlarm, Blood-Pressure
- FERAnoscope And Accessories
- EWOAudiometer
- DXQBlood Pressure Cuff
- FCYBulb, Inflation, For Endoscope
- HKICamera, Ophthalmic, Ac-Powered
- EMACement, Dental
- FDFColonoscope And Accessories, Flexible/Rigid
- HEXColposcope (And Colpomicroscope)
- BTICompressor, Air, Portable
- DSKComputer, Blood-Pressure
- DQKComputer, Diagnostic, Programmable
- FLLContinuous Measurement Thermometer
- DSIDetector And Alarm, Arrhythmia
- FJCDetector, Blood Level
- DPSElectrocardiograph
- GCPEndoscope, Ac-Powered And Accessories
- ISDExerciser, Measuring
- HLSExophthalmometer
- FDSGastroscope And Accessories, Flexible/Rigid
- HPQHeadlamp, Operating, Ac-Powered
- JYKHolder, Ear Speculum
- FFSImage, Illumination, Fiberoptic, For Endoscope
- CCWLaryngoscope, Rigid
- GCTLight Source, Endoscope, Xenon Arc
- FCWLight Source, Fiberoptic, Routine
- FSRLight, Headband, Surgical
- FSTLight, Surgical, Fiberoptic
- HJHLoupe, Binocular, Low Power
- FXXMask, Surgical
- KAIMirror, Ent
- BZQMonitor, Breathing Frequency
- DRTMonitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
- HLIOphthalmoscope, Ac-Powered
- HLJOphthalmoscope, Battery-Powered
- ERAOtoscope
- DQAOximeter
- HOOPerimeter, Ac-Powered
- DSBPlethysmograph, Impedance
- DSHRecorder, Magnetic Tape, Medical
- HKORefractometer, Ophthalmic
- HKMRetinoscope, Battery-Powered
- FRWScale, Patient
- INFScale, Platform, Wheelchair
- FRIScale, Stand-On, Patient
- HOYShield, Eye, Ophthalmic (Including Sunlamp Protective Eyewear And Post-Mydriatic Eyewear)
- FAMSigmoidoscope And Accessories, Flexible/Rigid
- EQHSource, Carrier, Fiberoptic Light
- HDGSpeculum, Vaginal, Metal, Fiberoptic
- HIBSpeculum, Vaginal, Nonmetal
- BZGSpirometer, Diagnostic
- HMFStand, Instrument, Ac-Powered, Ophthalmic
- DXNSystem, Measurement, Blood-Pressure, Non-Invasive
- IXFTest-Pattern, Radiographic
- ETYTester, Auditory Impedance
- GCWTransformer, Endoscope
- HJNTransilluminator, Battery-Powered
- EIAUnit, Operative Dental
- HQCUnit, Phacofragmentation
- CBKVentilator, Continuous, Facility Use
Recall records
| Recall | Product | Reason | Classification | Initiated | Status |
|---|---|---|---|---|---|
| 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 | If the device is exposed to fluid ingress and is used before the cleaning fluid has completely dried, there is a risk of the device overheating potentially causing a burn to the user or the ear canal of the patient | Class II | Open, Classified | |
| 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). | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock | Class II | Terminated | |
| Z-1672-2021 | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulatory and acute care settings. | Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock | Class II | Terminated | |
| 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 | A defective electrical component in the battery charging circuit in two lots of the ProBP 2400 may potentially cause an over-voltage battery charging condition when the device is connected to the external power supply/battery charger. This potential defect resides with the device, not the battery. The over-voltage condition can result in high NiMH battery temperatures that, in some cases, can reach levels sufficient to cause melting of the plastic battery door and other adjacent plastic and foam device components. | Class II | Terminated | |
| 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 | The firm became aware that the KleenSpec 788 Corded Illuminator has the potential to be incorrectly connected to a commonly available AC power cord instead of the illuminator low voltage transformer power cord which is supplied with the illuminator. This may result in a shattered lamp bulb and a potential electric shock hazard. | Class II | Terminated | |
| Z-0757-04 | 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 sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114 and 30502-214 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-2 and 637-5084-105-2 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0756-04 | 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 multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-114S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-105-1- Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0755-04 | 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 sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113 and 30502-213 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-2 and 636-5084-104-2 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0754-04 | 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 multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-113S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-104-1 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-753-04 | 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 sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112 and 30502-212 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-2, and 635-5084-103-2 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0752-04 | 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 multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-112S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-103-1 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0751-04 | 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, 671-5082-102-2, and sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111 and 30502-211 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-2 and 634-5084-102-2 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0750-04 | 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 multi-pack (1 of each size) with Part #5082-241-9 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance Healthcare ''Tactics'' label with Part # 30502-111S - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part # 5084-102-1 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0749-04 | 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 sold as part of a multi-pack (1 of each size) with Part #5082-241-10 - Welch Allyn Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #s 30502-110 and 30502-210 - Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #s 5084-101-2 and 633-5084-101-2 - Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0748-04 | 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 (1 of each size) with Part #5082-241-9 - firm on label is Welch Allyn, Inc., Skaneateles Falls, NY; Allegiance ''Tactics'' label with Part #30502-110S, firm on label is Allegiance Healthcare Corp., McGaw Park, IL; and Arden label with Part #5084-101-1, firm on label is Arden, Skaneateles, NY. | GMP deficiencies | Terminated | ||
| Z-0354-04 | Sure Temp Plus Model 690/692 Oral Temperature Probes | Mechanical setting errors that result in calibration errors. | Terminated | ||
| Z-0244-04 | 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'' represents the cuff size. (4 = 6.9 to 11.7 cm). These are sold in various configurations and assigned different part numbers. Devices are labeled as follows: Welch Allyn Tycos #5082-104-1 (10 pack/1 tube); Welch Allyn Tycos #5082-241-9 (5 pack/1 tube, multi-size pack); Allegiance Tactics #30502-113S (case of 40/1tube); Welch Allyn Tycos/Allegiance #5082-241-15 (5 pack/1 tube, multi-size pack); Firm on label: (1) Welch Allyn Tycos and Tycos/Allegiance label (package insert and shipping case only): ''Welch Allyn, Inc., Skaneateles Falls, NY''; (2) Allegiance Tactics label ''Distributed by: Allegiance Healthcare Corporation, McGaw Park, IL 60085-6787 USA'' | Incorrect location of inflatable portion of cuff that may result in cuff falling off patient's arm, error code when used with patient monitor, or an inaccurate reading. | Terminated |
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Data as of , FDA export datePage updated Source: openFDA, public domain