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 Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Class II Cardiovascular 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 Class II Cardiovascular
2023-03-15 K223381 iExaminer System with Panoptic Plus HKI Class II Ophthalmic
2022-10-28 K212473 Welch Allyn Connex Central Station MWI Class II Cardiovascular