WELCH ALLYN, INC.

FDA Device Registration & Listing · Skaneateles Falls, NY, US · Registration 1316463

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
1316463
FEI Number
1316463
Entity Name
WELCH ALLYN, INC.
City/State/Country
Skaneateles Falls, NY, US
Establishment Address
4341 STATE STREET RD., Skaneateles Falls, NY 13153, US
Establishment Type(s)
Develop Specifications But Do Not Manufacture At This Facility,Manufacture Medical Device
Owner / Operator
BAXTER HEALTHCARE CORPORATION (Owner Number: 1417572)
Owner / Operator Contact Address
One Baxter Parkway, Deerfield, IL 60015, US
Initial Importer Flag
Y
Expiration Date (Year)
2026
510(k) Number
K930604
PMA Number
N/A

All Registered Proprietary Names

901057 Spot Vital Signs 4400 Rigid Laryngoscope - Fiber Optic Laryngoscopes, standard laryngoscope and accessories TruLight 1000 Examination Light and accessories [Baxter] Green Series Exam Lights (Light IV, 300, 600, 900) and Accessories [a Welch Allyn, Inc. Tijuana Product] Sphygmomanometers Bronze Series - DS44, DS54 Aneroids and accessories Gold Series - DS56, DS66 Aneroids and accessorie Durashock Sphygmomanometers and accessories Blood Pressure Cuff- Durashock Sphygmomanometers multiple and Accessories Silver Series - DS45, DS55, DS65 Aneroids and accessories Platinum Series - DS58, DS48, DS48A Aneroids and accessories Service Parts Only 767 Integrated Wall Systems and Wall Transformer Sets, Accessories Quinton CR60/TM65 Treadmill X-Scribe / XScribe Stress Exercise Testing System Quinton Q-Stress Stress Exercise Testing System Sleeve Cuff Kit ABPM 6100 Sleeve Cuff, various sizes ABPM 6100 service only Welch Allyn Diagnostic Cardiology Suite Welch Allyn Diagnostic Cardiology Suite - Spirometry 901128 CARDIOPULMONARY ECG SYSTEM Welch Allyn Diagnostic Cardiology Suite - ECG Medikro Spirometer Kits & accessories (410027, 410370, 720705, 720706, 720707, 100680, 720704, 720708, 720855) CP 150 Electocardiograph Devices and accessories Spot Vision Screener (901029) VS100 Vision Screener (901029) Ophthalmic Refractometer Devices - Spot VS100 and SureSight Series and accessories AC Powered Ophthalmoscope - BIO Binocular Indirect Ophthalmoscope and accessories H-Scribe 5 Holter Analysis system Hscribe Holter Analysis System H-Scribe Holter Analysis System iExaminer system with Panoptic Plus Burdick ELI 230 /BUR 230 Electrocardiograph ELI 230/ELI 230 Electrocardiograph/ ELI 230 Cardiograph Anoscope and/or accessories - Disposable Anoscope ELI 250c / ELI 250Rx Electrocardiograph Burdick ELI 250c/Burdick 250c Electrocardiograph BUR 250c Batter Powered Transilluminator - Fiber Optic Transilluminators and accessories iExaminer Resolution Test Card - for OTOSCOPE iEXAMINER APP iOS for Otoscope iEXAMINER APP ANDR for Otoscope SureTemp Plus Probes and Probe Covers; Electronic Thermometry BRAUN THERMOSCAN PRO 4000 SERIES AND BRAUN THERMOSCAN IRT 4000 SERIES MODEL 6021791-PRO 4000 SERIES, 6022790-IRT 4000 SE Battery Door (EU) Pro6000 Bulk Pack 4th ed SureTemp Plus Electronic Thermometers (690 & 692 Series) and Accessories Thermometer Avita 410671 Care Temp Touch Free Thermometer Accessories 901094 Non Contact Thermometer PRO6000 Small Cradle & Charge Doc EU Thermometer, electronic, clinical Thermometer with Charge Dock; 6' Tether for PRO 6000 Care Temp Touch Free Thermometer #105801 Thermometer Charge Dock Only Braun Thermoscan Pro 6000 Battery Door (US) Therm w/ large cradle 4th ed Them w/ large cradle PRO6000 Bulk Pack Probe Covers 9' Tether for PRO6000 PRO6000 Small Cradle PRO6000 Large Cradle Rechargeable Battery PRO6000 PRO6000 Charge Station (US) Ophthalmoscope, battery-powered Stow-A-Weigh Wheelchair Scale Oversized Wheelchair Scale Wheelchair Scale Bariatric Wheelchair Scale Stow-A-Weigh Stretcher Scale Loupe, Binocular, Low Power - Flat Surface Magnifier, LumiView Portable Binocular Microscope Accessories Green Series Portable Headlights - Solid State Portable Headlight and accessories Pocket LED Ophthalmoscope Ophthalmoscope and Accessories Pocket Scope Ophthalmoscope Welch Allyn FlexiPort Blood Pressure Cuffs (FlexiPort Blood Pressure Cuffs) Universal Desk Charger for Lithium Ion and NiCad Handles, P/N 71110, 71140 Series Accessories - Ophthalmoscope (e.g., PanOptic, etc.) and Otoscope (e.g., MacroView, etc.) RetinaVue Network Reusable One-piece, Soft Disposable One-Piece, Vinyl Disposable One-Piece and accessories Flexiport Blood Pressure Cuffs and accessories ELI 380 Electrocardiograph / ELI 380 / ELI 380 Cardiograph ELI 380 ERGO GS777 Integrated Wall Systems w/117 LED Ophthalmoscope Diagnostic Set w/117 LED Ophthalmoscope AC Powered Ophthalmoscope Devices - Compacset Dignosics Set, Klinic Ophthalmoscopes, Various Models and accessories; 117 Audiometer Devices - AudioScope 3 Screening Audiometer and accessories Welch Allyn Connex Central Station (Connex CS) v. 1.8.7 Model 901066 Monitoring Station Welch Allyn Connex Central Station (Connex CS) v. 1.8.5 Epiphany Cardio Server Mobile Connex Cardio R-Scribe Electrocardiograph Cardiac Monitor (Including Cardiotachometer And Rate Alarm) FlexiPort EcoCuffs and accessories (ECOCUFF-09, -10, -11, -12, -MLT) Two-Piece Blood Pressure Cuffs and accessories Tycos 509 Wall and Mobile Aneroids and accessories 767 Wall & Mobile Aneroids and Accessories Service Parts Only One-Piece Disposable Neonate Blood Pressure Cuffs and accessories Endoscope and/or accessories - Disposable Sigmoidoscope 800 Series Cordless Illumination System Obstetric-gynecologic Specialized Manual Instrument - KleenSpec Single Use Vaginal Speculum Accessories 790 Series Cordless Iluminator and wire Illuminator KleenSpec Disposable Vaginal Speculum and accessories Oximeter, Thermometer and accessories; ProBP 3400 Series and accessories Blood Pressure Non-invasive Measurement System, Devices and accessories Ophthalmoscope and Accessories Pocket LED Ophthalmoscope Pocket Scope Ophthalmoscope Accessories Battery Powered Retinoscope Devices - Elite Streak and Spot Retinoscopes i-Examiner (Panoptic Ophthalmosope and iPhone) and Accessories RV700 RV100 Pro RV100 RetinaVue 700 Imager Eye-Fundus Camera - RetinaVue 100 Imager Spot Vision Screener Surveyor S19 Anoscope and Accessories - Fiber Optic Anoscope, Op77E Rating Anoscope, Rotating Anoscope, Standard Anoscope Endoscope Inflation Bulb - Endoscope Insufflation System and accessories Connex Central Station (Connex CS), Model 901066 Monitoring Station and Connex CS Accessories Accessories - Software and Hardware Blood Pressure Cuffs- Omni-Kuff and accessories iExaminer (PanOptic Ophthalmoscope and iPhone) and accessories Bariatric Stand-On Scale [Skan spec dev] Mobile Bariatric Stand-On Scale [Skan spec dev] and accessory Height Gauge Geriatric Physician's Stand-On Scale Mobile Stand-On Scale [Skan spec dev] and accessory Height Gauge T-RPM-SCALE100 [Skan contr. mfg] TAA Remote Monitoring Scale [Skan contr. mfg] In-Floor Stand-On Scale [Skan spec dev] Low-Profile Stand-On Scale [Skan spec dev] Portable Stand-On Scale [Skan spec dev] Physician's Stand-On Scale Stow-A-Weigh Stand-On Scale [Skan spec dev] ERGOSELECT 100 K/P, ERGOSELECT 200 K/P Burdick ELI 280/BUR 280 Electrocardiograph McKesson Lumeon Series Burdick ELI 280 ELI 280 Electrocardiograph / ELI 280 Cardiograph Dispenser for 524 Series Disposable Ear Spec Pulmonary Server ECG Management System Cardio Server ECG Management System Digital MacroView, MacroView, 3.5V Diagnostic, Pneumatic, Op77E-Rating, PocketScope, Pocket Jr. Welch Allyn MacroView Plus Oto for iEx Welch Allyn MacroView Plus iExaminer Kit Welch Allyn LumiView Clear Single-Use Ear Specula Pocket LED Otoscopes (multi-colors) and accessories Welch Allyn LED Otoscope Compacset Portable Dignostic Set, Lumiview w/Various Transformer Sets and Accessories Welch Allyn MacroView Basic Otoscope Reusable and Disposable Specula,Dispensers Otoscope and Accessories BLK Pocket LED Otoscope H12+ Holter Recorder Braun Thermoscan PRO 6000 Ear Thermometer Omni cuffs and accessories Blood Pressure Cuffs- Balanced Nylon Bladders and accessories

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-01-11
CCW Laryngoscope, Rigid Anesthesiology Class 1 868.5540 1978-12-29
KZF Device, Medical Examination, Ac Powered General Hospital Class 1 880.6320 2022-01-10
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-01-11
GCW Transformer, Endoscope Gastroenterology, Urology Class 2 876.1500 2022-01-11
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-01-11
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2022-01-10
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-11
BZG Spirometer, Diagnostic Anesthesiology Class 2 868.1840 2022-01-11
HKO Refractometer, Ophthalmic Ophthalmic Class 1 886.1760 2022-01-11
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2022-01-11
MLO Electrocardiograph, Ambulatory, With Analysis Algorithm Cardiovascular Class 2 870.2800 2022-01-10
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2023-10-19
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2022-01-11
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
HJN Transilluminator, Battery-Powered Ophthalmic Class 1 886.1945 2022-01-11
IXF Test-Pattern, Radiographic Radiology Class 1 892.1940 2022-01-11
LMA Digitizer, Image, Radiological Radiology Class 2 892.2030 2022-01-11
SDV Clinical Electronic Thermometer General Hospital Class 2 880.2910 2026-02-16
HLJ Ophthalmoscope, Battery-Powered Ophthalmic Class 2 886.1570 2023-10-11
INF Scale, Platform, Wheelchair Physical Medicine Class 1 890.3940 2022-01-11
HJH Loupe, Binocular, Low Power Ophthalmic Class 1 886.5120 2022-01-11
FSR Light, Headband, Surgical Ophthalmic Class 2 886.4335 2023-09-19
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2022-01-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2025-12-17
HLS Exophthalmometer Ophthalmic Class 1 886.1270 2024-02-21
NFJ System, Image Management, Ophthalmic Radiology Class 2 892.2050 2022-01-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-01-11
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2022-01-11
EWO Audiometer Ear, Nose, Throat Class 2 874.1050 2022-01-11
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2025-04-07
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2025-04-07
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-03-18
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2025-09-26
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-01-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-01-11
FAM Sigmoidoscope And Accessories, Flexible/Rigid Gastroenterology, Urology Class 2 876.1500 2022-01-11
HIB Speculum, Vaginal, Nonmetal Obstetrics/Gynecology Class 2 884.4530 2023-09-19
DQA Oximeter Cardiovascular Class 2 870.2700 2022-01-11
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-01-11
DXN System, Measurement, Blood-Pressure, Non-Invasive Cardiovascular Class 2 870.1130 2022-01-11
HLI Ophthalmoscope, Ac-Powered Ophthalmic Class 2 886.1570 2023-07-17
HKM Retinoscope, Battery-Powered Ophthalmic Class 1 886.1780 2022-01-11
PJZ Camera, Ophthalmic, General-Use Ophthalmic Class 2 886.1120 2022-01-11
DQA Oximeter Cardiovascular Class 2 870.2700 2022-01-10
MSX System, Network And Communication, Physiological Monitors Cardiovascular Class 2 870.2300 2022-01-10
DSI Detector And Alarm, Arrhythmia Cardiovascular Class 2 870.1025 2022-01-10
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2022-01-10
DSB Plethysmograph, Impedance Cardiovascular Class 2 870.2770 2022-01-10
MLD Monitor, St Segment With Alarm Cardiovascular Class 2 870.1025 2022-01-10
DSJ Alarm, Blood-Pressure Cardiovascular Class 2 870.1100 2022-01-10
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
FER Anoscope And Accessories Gastroenterology, Urology Class 2 876.1500 2022-01-11
FCY Bulb, Inflation, For Endoscope Gastroenterology, Urology Class 1 876.1500 2022-01-11
MWI Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.2300 2022-01-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-01-11
HKI Camera, Ophthalmic, Ac-Powered Ophthalmic Class 2 886.1120 2022-01-11
FRI Scale, Stand-On, Patient General Hospital Class 1 880.2700 2022-01-11
ISD Exerciser, Measuring Physical Medicine Class 2 890.5360 2024-07-25
DPS Electrocardiograph Cardiovascular Class 2 870.2340 2022-01-10
JYK Holder, Ear Speculum General, Plastic Surgery Class 1 878.1800 2024-07-22
DQK Computer, Diagnostic, Programmable Cardiovascular Class 2 870.1425 2022-03-18
ERA Otoscope Ear, Nose, Throat Class 1 874.4770 2022-01-11
DSH Recorder, Magnetic Tape, Medical Cardiovascular Class 2 870.2800 2022-01-10
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2022-01-11
DXQ Blood Pressure Cuff Cardiovascular Class 2 870.1120 2022-01-11

Official Correspondent

Maha Nolasco

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

BAXTER HEALTHCARE CORPORATION
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3014226707 BARDY DIAGNOSTICS, INC. Bellevue, WA, US
3019257308 VIDEOMED SRL LIMENA Padova, IT
1314492 Baxter Healthcare Corporation MEDINA, NY, US
3007143268 Baxter Medical Systems GmbH + Co. KG SAALFELD Thuringia, DE
8010130 BAXTER SA LESSINES Hainaut, BE

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K071802 Mammendorfer Institut Fur Physik Und Medizin GmbH TESLA GUARD, MODEL EFT G04 2007-11-09
K124061 Invivo Corporation MRI PATIENT MONITORING SYSTEM (MODEL 865214) 2013-02-22
K101264 Remote Diagnostic Technologies , Ltd. TEMPUS IC PROFESSIONAL PATIENT MONITOR 2010-05-11
K113105 Remote Diagnostic Technologies , Ltd. TEMPUSIC PATIENT MONITOR 2011-12-15
K134014 Remote Diagnostic Technologies , Ltd. TEMPUS PRO ACCESSORIES (ULTRASOUND & VIDEO LARYNGOSCOPE PROBE) 2014-08-12

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
Z-0001-2015 Invivo Corporation 2
Philips Expression MR200 MRI Patient Monitoring System Model 866120
Z-0004-2023 Philips North America Llc 2
MR Patient Care Portal 5000 (Desktop Unit), Model Number 453564792561 This is a component of product number 866162.
Z-0011-04 GE Medical Systems Information Technologies 2
Power cord manufactured by ElectriCord Manufacturing Company , P/N 316579, used with DINAMAP Patient Monitors as Follows: DINAMAP PRO Series, DINAMAP PRO 1000 Monitor under both the Critikon and GE Medical Systems. The company name EliectriCord is on the power cord plug.
Z-0042-2015 Mckesson Information Solutions LLC 2
McKesson Cardiology" Hemo intended for complete physiological/hemodynamic monitoring, clinical data acquisition, medical image and data processing, and analytical assessment.
Z-2183-2011 Remote Diagnostic Technologies Ltd. The Old Coach House, The Av. Farleigh Wallop, Basingstoke Hampshire United Kingdom 2
TEMPUS IC PROFESSIONAL Patient Monitor, Part No. 00-1002, Manufactured by: Remote Diagnostics Technologies Ltd., The Old Coach House, Farleigh Wallop, Hants, UK RG25 2HT. Indicated for 3 Lead ECG monitoring and 12 Lead ECG recording, non-invasive blood pressure (NIBP), respiration, end-tidal C02 (ETCO 2), pulse oximetry (SP02) and tympanic temperature.

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1316463. Last updated year: 2026. Please use registration number 1316463 when referencing this establishment in official correspondence.
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