Data / Medical devices / United States / Welch Allyn, Inc.
Welch Allyn, Inc.: FDA-registered device maker in Skaneateles Falls, NY, United States, 50 510(k) clearances
Welch Allyn, Inc. is registered with the FDA (registration 1316463) in Skaneateles Falls, NY, United States. It lists 53 device types. The FDA files 50 510(k) clearances under its listings, the newest dated December 16, 2025. 6 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.
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- FDA registration number
- 1316463
- Address
- 4341 State Street RD., Skaneateles Falls, NY, United States, 13153
- Owner or operator
- BAXTER HEALTHCARE CORPORATION (1417572)
- Roles
- Complaint file establishment, Manufacturer, Repackager or relabeler, Specification developer
- First device listed
- December 29, 1978
- Registered through
- 2026
- Brand names listed
- #156-3 & 156-4, 39000 series Blood Pressure Cuff, 719-3 Li-Ion Plus USB Handle for Desk Charger, 719-DSK Welch Allyn Universal Desk Charger, 719-USB USB POWER SUPPLY,5V,1.4A,USB-A, 767 Integrated Wall Systems and Wall Transformer Sets, Accessories, 767 Wall & Mobile Aneroids and Accessories, 790 Series Cordless Iluminator and wire Illuminator and more
Devices it lists
510(k) clearances
The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.
| Decided | 510(k) number | Device | Product code | Decision | Applicant | Source |
|---|---|---|---|---|---|---|
| December 16, 2025 | K251745 | Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) | DXQ | Substantially Equivalent | Baxter Healthcare Corporation | accessdata.fda.gov |
| July 13, 2025 | K243598 | Welch Allyn Connex® 360 (Multiple) | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov | |
| December 20, 2024 | K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | MWI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| March 15, 2023 | K223381 | iExaminer System with Panoptic Plus | HKI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| October 28, 2022 | K212473 | Welch Allyn Connex Central Station | MWI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 10, 2019 | K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | BZG | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 4, 2018 | K173765 | Surveyor Patient Monitor | MHX | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| July 30, 2018 | K181720 | Epiphany Cardio Server Mobile | DQK | Substantially Equivalent | Epiphany Healthcare, LLC | accessdata.fda.gov |
| July 16, 2018 | K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | NFJ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| August 11, 2017 | K170037 | Breathe Technologies Life2000 Ventilation System | CBK | Substantially Equivalent | Breathe Technologies | accessdata.fda.gov |
| June 30, 2017 | K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor | MHX | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| March 1, 2016 | K152748 | Braun Thermoscan PRO 6000 Ear Thermometer | FLL | Substantially Equivalent | Kaz USA, Inc (A Subsidiary of Helen of Troy, Inc) | accessdata.fda.gov |
| February 26, 2016 | K152626 | H3+ Holter Recorder | MWJ | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| January 6, 2016 | K152944 | Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| December 19, 2014 | K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | MWI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| September 5, 2014 | K142105 | ELI 380 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| July 11, 2014 | K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | DPS | Substantially Equivalent | Welch Allyn | accessdata.fda.gov |
| January 31, 2014 | K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | MWI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| December 20, 2012 | K121405 | PANOPTIC | HKI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| November 5, 2012 | K122058 | FLEXIPORT ECOCUFF | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| November 2, 2012 | K122401 | TANGO M2 BLOOD PRESSURE MONITOR | DXN | Substantially Equivalent | Suntech Medical, Inc. | accessdata.fda.gov |
| August 2, 2012 | K122073 | ELI 280 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| July 19, 2012 | K120865 | RSCRIBE ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| July 9, 2010 | K101680 | WELCH ALLYN SPOT VITAL SIGNS LXI MODEL 45000 SERIES | DXN | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| July 2, 2010 | K101403 | ELI 250 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| June 18, 2010 | K101115 | ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150 | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| April 16, 2010 | K100127 | ELI 230 ELECTROCARDIOGRAPH | DPS | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| March 9, 2009 | K082478 | WELCH ALLYN CARDIOPERFECT WORKSTATION SOFTWARE (CPWS) V 1.62 | BZG | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| August 15, 2008 | K080189 | TEMPA-KUFF SOFT BLOOD PRESSURE CUFF, MODEL 39XXX ; VINYL,MODEL 99XXX | DXQ | Substantially Equivalent | Trimline Medical Products Corp. | accessdata.fda.gov |
| December 18, 2007 | K070060 | WELCH ALLYN FLEXIPORT DISPOSABLE BLOOD PRESSURE CUFF (ONE-PIECE); REUSABLE BLOOD PRESSURE CUFF (ONE-PIECE) | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 15, 2006 | K053381 | WELCH ALLYN CONNEX VITAL SOLUTIONS SOFTWARE | DQA | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| April 27, 2006 | K053078 | ERGOSELECT 100 K/P, ERGOSELECT 200 K/P | ISD | Substantially Equivalent | Ergoline GmbH | accessdata.fda.gov |
| November 1, 2005 | K052883 | CARDIOSERVER | DQK | Substantially Equivalent | Datrix | accessdata.fda.gov |
| September 26, 2005 | K051730 | MATRIX HOLTER SYSTEM, MODEL M12 | MLO | Substantially Equivalent | Global Instrumentation, LLC | accessdata.fda.gov |
| August 24, 2005 | K050896 | H12+ HOLTER RECORDER | DSH | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| June 27, 2002 | K021756 | WELCH ALLYN ABPM 6100 | DXN | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| August 17, 2001 | K012455 | WELCH ALLYN DURASHOCK BLOOD PRESSURE SYSTEM | DXQ | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 11, 2001 | K004017 | H-SCRIBE | MLO | Substantially Equivalent | Mortara Instrument, Inc. | accessdata.fda.gov |
| January 25, 2001 | K003376 | WELCH ALLYN 11800 OPTHALMOSCOPE | HLI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| April 4, 1995 | K950461 | WELCH ALLYN OPHTHALMOSCOPE | HLI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 21, 1993 | K930023 | MODEL #12000 BINOCULAR INDERECT OPHTHALMOSCOPE | HLI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| April 30, 1993 | K930604 | BALANCED(TM) NYLON BLADDER | DXQ | Substantially Equivalent | Pymah Corp. | accessdata.fda.gov |
| January 13, 1989 | K884421 | PRE-GAGED BALANCED CUFF W/SYLGARD ANTIMICRO. TREAT | DXQ | Substantially Equivalent | Pymah Corp. | accessdata.fda.gov |
| June 10, 1986 | K861516 | WELCH ALLYN TYMPANOMETER | ETY | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| February 19, 1981 | K810227 | MODEL #53110 DISPOSABLE ANOSCOPE | FER | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| April 23, 1979 | K790610 | SIGMOIDOSCOPE TIPLESS | FAM | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| November 22, 1977 | K771864 | WALL TRANSFORMERS 74710 & 74910 | GCW | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| June 1, 1977 | K770906 | ANOSCOPE, OPTIC, FIBER | FER | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| May 6, 1977 | K770768 | OPHTHALMOSCOPE, MODEL #11100 | HLI | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
| February 18, 1977 | K770291 | SIGMOIDOSCOPE, DISPOSABLE, MODEL #53125 | FAM | Substantially Equivalent | Welch Allyn, Inc. | accessdata.fda.gov |
Recalls
Recall events where this establishment is the recalling firm, matched on its FEI.
| Initiated | Event | Class | Status | Product | Reason | Source |
|---|---|---|---|---|---|---|
| July 20, 2021 | 88481 | Class II | Ongoing | 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 | 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 | accessdata.fda.gov |
| April 22, 2021 | 87749 | Class II | Terminated | 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 | accessdata.fda.gov |
| February 27, 2017 | 76552 | Class II | Terminated | 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, R | 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 te | accessdata.fda.gov |
| October 2, 2015 | 72228 | Class II | Terminated | 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 ON | 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. | accessdata.fda.gov |
| March 1, 2004 | 28428 | Not yet classified | Terminated | 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 | GMP deficiencies | accessdata.fda.gov |
| October 27, 2003 | 27522 | Not yet classified | Terminated | 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. | 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. | accessdata.fda.gov |
Compare with other makers
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- All makers of System, Measurement, Blood-Pressure, Non-Invasive
- All makers of Digitizer, Image, Radiological
- All makers of Ophthalmoscope, Ac-Powered
Updated December 16, 2025. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.