Welch Allyn Inc
FDA Regulatory Profile
Welch Allyn Inc appears in FDA public data with 5 recalls, 112 510(k) clearances, 7 FDA inspections, and 0 compliance actions on record. Its most recent recall (Z-2482-2021, Class II) was initiated on July 20, 2021. Its most recent 510(k) clearance was granted on July 13, 2025.
Summary
- Total Recalls
- 5
- 510(k) Clearances
- 112
- Inspections
- 7
- Compliance Actions
- 0
Recent Recalls
| Number | Class | Product | Date |
|---|
| Z-2482-2021 | Class II | Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body t | July 20, 2021 |
| Z-1672-2021 | Class II | GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended | April 22, 2021 |
| Z-1673-2021 | Class II | ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34X | April 22, 2021 |
| Z-1777-2017 | Class II | Welch Allyn ProBP 2400 Digital Blood Pressure Device #2400, REF 901096, Rx ONLY, Made in China --- D | February 27, 2017 |
| Z-0169-2016 | Class II | Welch Allyn KleenSpec Corded Illumination System, Vaginal Speculum Lighting System, Model Number 78x | October 2, 2015 |
Recent 510(k) Clearances
| K-Number | Device | Date |
|---|
| K243598 | Welch Allyn Connex® 360 (Multiple) | July 13, 2025 |
| K241411 | Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) | December 20, 2024 |
| K223381 | iExaminer System with Panoptic Plus | March 15, 2023 |
| K212473 | Welch Allyn Connex Central Station | October 28, 2022 |
| K191013 | Welch Allyn Diagnostic Cardiology Suite 2.X.X with Spirometry option | September 10, 2019 |
| K181016 | Welch Allyn RetinaVue Network REF 901108 PACS Medical Image System | July 16, 2018 |
| K171621 | Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Sign | June 30, 2017 |
| K142356 | Connex Spot Monitor,901058 Vital Signs Monitor Core | December 19, 2014 |
| K141582 | CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION | July 11, 2014 |
| K132807 | MONITORING STATION, CONNEX(R) CENTRAL STATION (CS) | January 31, 2014 |
| K132808 | VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR | November 20, 2013 |
| K131573 | CP150 ELECTROCARDIOGRAPH | July 3, 2013 |
| K121405 | PANOPTIC | December 20, 2012 |
| K122058 | FLEXIPORT ECOCUFF | November 5, 2012 |
| K121013 | CONNEX VITAL SIGNS MONITOR 6000 SERIES | July 26, 2012 |
| K120774 | ACUITY CENTRAL MONITORING STATION OR ACUITY CENTRAL MONITORING SYSTEM, MOBILE ACUITY LT, MOBILE ACUI | April 10, 2012 |
| K120743 | SPECULUM, VAGINAL, NONMETAL | March 23, 2012 |
| K120343 | CONNEX WORKSTATION | February 24, 2012 |
| K112687 | CONNEX(R) VITAL SIGNS MONITOR 6000 SERIES | November 22, 2011 |
| K110516 | CONNEX VITAL SIGNS MONITOR 6000 SERIES | June 1, 2011 |