# Welch Allyn, Inc.

- Location (FDA's records): Skaneateles Falls, NY
- FDA decisions: 112 (1977–2025): 112 510(k) clearances
- Names in FDA's records: Welch Allyn, Inc. (111); Welch Allyn (1)
- Product codes: MWI (12), DXN (12), ERA (9), KZF (6), HLI (5), DPS (4), BZG (4), FAM (4), DXQ (4), HIB (3), DQA (3), FCW (2)
- 510(k) review time since 2016: median 137 days, against 174 for FDA's reviews in the same codes and years (2 of 6 faster)
- Predicates its devices cite: 74 (35 its own); citations of its devices by later devices: 108 (35 its own)
- Recalls linked to its devices: 19 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Firms whose devices it cites most
- Welch Allyn Protocol, Inc.: 5 (https://510kreport.com/company/welch-allyn-protocol)
- Masimo Corporation: 4 (https://510kreport.com/company/masimo)
- Nellcor Puritan Bennett, Inc.: 3 (https://510kreport.com/company/nellcor-puritan-bennett)
- Cardio Control BV: 2 (https://510kreport.com/company/cardio-control)
- Caird Technology: 2 (https://510kreport.com/company/caird-technology)
- Philips Medical Systems, Inc.: 2 (https://510kreport.com/company/philips-medical-systems)
- Tycos Instruments, Inc.: 2 (https://510kreport.com/company/tycos-instruments)
- Protocol Systems, Inc.: 2 (https://510kreport.com/company/protocol-systems)

## Firms that cite its devices most
- Global Instrumentation, LLC: 3 (https://510kreport.com/company/global-instrumentation)
- Akos Biomedical, Inc.: 3 (https://510kreport.com/company/akos-biomedical)
- Sapimed S.P.A.: 2 (https://510kreport.com/company/sapimed)
- Skanray Technologies Private Limited: 2 (https://510kreport.com/company/skanray-technologies-private)
- Masimo Corporation: 2 (https://510kreport.com/company/masimo)
- Medikro OY: 2 (https://510kreport.com/company/medikro)
- Welch Allyn Protocol, Inc.: 2 (https://510kreport.com/company/welch-allyn-protocol)
- Optomed OY: 2 (https://510kreport.com/company/optomed)

## Its most-cited devices
- K955635: Video Colposcope/Vertical Rolling Base/Swing Arm Stand (1996), cited by 8
- K052160: Acuity Central Station, Model 020XXXXX (Note:  Xxxxx = Various Config.) (2005), cited by 6
- K052158: Welch Allyn Cardioperfect Workstation Version 1.5.0 Software (2005), cited by 5
- K040490: Welch Allyn Spot Ultra Vital Signs Device (2004), cited by 5
- K101680: Welch Allyn Spot Vital Signs Lxi Model 45000 Series (2010), cited by 5
- K001265: Welch Allyn Instrument Interface Module (2000), cited by 3

## Recent decisions
- K243598: Welch Allyn Connex® 360  (Multiple) (Jul 13, 2025)
- K241411: Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) (Dec 20, 2024)
- K223381: iExaminer System with Panoptic Plus (Mar 15, 2023)
- K212473: Welch Allyn Connex Central Station (Oct 28, 2022)
- K191013: Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option (Sep 10, 2019)
- K181016: Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System (Jul 16, 2018)
- K171621: Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor (Jun 30, 2017)
- K142356: Connex Spot Monitor,901058 Vital Signs Monitor Core (Dec 19, 2014)

Source page: https://510kreport.com/company/welch-allyn