510(k) Report

FDA applicant

Welch Allyn, Inc.

Skaneateles Falls, NY112 decisions1977–202519 recalls

FDA records 112 decisions for Welch Allyn, Inc. (Skaneateles Falls, NY) from 1977 to 2025: 112 510(k) clearances. Most are in product codes MWI (Monitor, Physiological, Patient (Without…) and DXN (System, Measurement, Blood-Pressure…). Since 2016 its 510(k)s took a median of 137 days from receipt to decision, against 174 for FDA’s reviews in the same codes and years. Its devices cite 74 predicates, 35 of them its own earlier devices. 19 recalls are linked to its devices.

FDA’s records also spell it “Welch Allyn”.

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) refreshed weekly, last Nov 3, 2026

FIG. A — Illustration, cardiovascular panel, where it files most

How often FDA has decided Welch Allyn, Inc.’s devices, and how often a recall has named them.

FDA decisions per year

1in 2025

2007: 42009: 12010: 32011: 22012: 62013: 22014: 32017: 12018: 12019: 12022: 12023: 12024: 12025: 1
2007high 6 (2012) · low 0 (2008)2026

2026 so far, outlined.

Recalls per year

10in 2025

2009: 22011: 12015: 12021: 12023: 12024: 32025: 10
2007high 10 (2025) · low 0 (2007)2026

Class I Class II/III not classified

FIG. 1 — Welch Allyn, Inc. by year, 2007–2026Sources: FDA decision databases, recall and enforcement reports · Data through Oct 25, 2026

Planning a device like Welch Allyn, Inc.’s? A 510(k) Report ranks candidate predicates for your device by lineage, citations and recall history, with the review-time outlook.

See the 510(k) Report

Which product codes does it file in?

  • MWIMonitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)12decisions
  • DXNSystem, Measurement, Blood-Pressure, Non-Invasive12decisions
  • ERAOtoscope9decisions
  • KZFDevice, Medical Examination, Ac Powered6decisions
  • HLIOphthalmoscope, Ac-Powered5decisions
  • DPSElectrocardiograph4decisions

Also: BZG (4), FAM (4), DXQ (4), HIB (3), DQA (3), FCW (2).

How long do its 510(k) reviews take?

Since 2016, its 6 510(k)s took a median of 137 days from FDA’s receipt to its decision. For 510(k)s in the same product codes and years, FDA’s median was 174 days; 2 of its 6 were faster than that.

Whose devices does it build on?

Its devices cite 74 predicates; 35 are its own earlier devices. The firms it cites most:

Who builds on its devices?

Later devices cite its devices 108 times; 35 of those are its own. The firms that cite it most:

Which of its devices are cited most?

Its devices that later submissions most often claim equivalence to.

  • K955635Video Colposcope/Vertical Rolling Base/Swing Arm StandWelch Allyn, Inc. · 19968cite it
  • K052160Acuity Central Station, Model 020XXXXX (Note: Xxxxx = Various Config.)Welch Allyn, Inc. · 20056cite it
  • K052158Welch Allyn Cardioperfect Workstation Version 1.5.0 SoftwareWelch Allyn, Inc. · 20055cite it
  • K040490Welch Allyn Spot Ultra Vital Signs DeviceWelch Allyn, Inc. · 20045cite it
  • K101680Welch Allyn Spot Vital Signs Lxi Model 45000 SeriesWelch Allyn, Inc. · 20105cite it
  • K001265Welch Allyn Instrument Interface ModuleWelch Allyn, Inc. · 20003cite it

What has FDA decided for it lately?

  • K243598Welch Allyn Connex® 360 (Multiple)Welch Allyn, Inc. · 2025
  • K241411Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM)Welch Allyn, Inc. · 20241 recall
  • K223381iExaminer System with Panoptic PlusWelch Allyn, Inc. · 2023
  • K212473Welch Allyn Connex Central StationWelch Allyn, Inc. · 2022
  • K191013Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry optionWelch Allyn, Inc. · 20191 recall
  • K181016Welch Allyn RetinaVue Network REF 901108 PACS Medical Image SystemWelch Allyn, Inc. · 2018
  • K171621Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs MonitorWelch Allyn, Inc. · 20173 recalls
  • K142356Connex Spot Monitor,901058 Vital Signs Monitor CoreWelch Allyn, Inc. · 20143 recalls

All 111 as Welch Allyn, Inc. →The one decision as Welch Allyn →

What has been recalled?

19 recalls linked to its devices; the latest:

  • K030580Oral Probe (Product code 02893-000), accessory used with Welch Allyn SureTemp Plus 690…Sep 17, 2025Class II
  • K171621Welch Allyn Connex Vital Signs Monitor (CVSM):Mar 24, 2025Class II
  • K141582Welch Allyn CP150 Electrocardiograph:Mar 24, 2025Class II
  • K241411Welch Allyn CONNEX Accessory Power Management Stand:Mar 24, 2025Class II
  • K070060Welch Allyn 2-Piece Reusable Blood Pressure Cuff Kits labeled as: 1. WELCH ALLYN 2-Piece…Mar 21, 2025Class II
  • K171621Welch Allyn Welch Allyn Connex Spot Monitor, Product Code/ Part Numbers: 1) 73WT-B; 2)…Mar 21, 2025Class II

Other applicant names beginning “Welch”

FDA records each applicant name separately; these may or may not be the same firm.

Welch Allyn Protocol, Inc. 7