Chrysalis Intelligence · Sponsors · Welch Allyn, Inc.

Welch Allyn, Inc.

Skaneateles Falls, NY, US · 4 510(k) clearances · 3 recalls

Total clearances
4
2022-10-28 → 2025-07-13
Last 12 months
0
Product codes
3
Most recent
2025-07-13
Trend

Clearance cadence by quarter

Portfolio

Product codes worked

Code Device name Class Specialty Clearances Most recent
MWI 2 2024-12-20
1 2025-07-13
HKI Camera, Ophthalmic, Ac-Powered Class II Ophthalmic 1 2023-03-15
Safety

Recalls (3)

Class I (serious)
0
Risk of injury / death
Total recalls
3
Currently ongoing
1
Most recent
2021-07-20
DateSeverityStatusRecall # ProductCodeReason
2021-07-20 Class II Ongoing Z-2482-2021 Braun ThermoScan PRO 6000 Ear Thermometer-indicated for the intermittent measurement of human body temperature for patie… 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 caus…
2021-04-22 Class II Terminated Z-1673-2021 ProBP 3400 Digital Blood Pressure Device ((handheld, desk mount, wall mount models) Model: 34XFHT-B Intended: P… Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
2021-04-22 Class II Terminated Z-1672-2021 GS777 Wall Transformer Model: 77710 Intended Use: The GS777 Wall Transformer is intended for use in ambulato… Potential Risk of fluid ingress to the power supplies, resulting in risk of an internal electrical short and possible electrical shock
Filings

All 510(k) clearances (4)

Date K-number Device Code Class Specialty
2025-07-13 K243598 Welch Allyn Connex® 360 (Multiple)
2024-12-20 K241411 Welch Allyn Connex® Spot Monitor; 901058 Vital Signs Monitor Core (CSM) MWI
2023-03-15 K223381 iExaminer System with Panoptic Plus HKI Class II Ophthalmic
2022-10-28 K212473 Welch Allyn Connex Central Station MWI