Cleared Traditional

Welch Allyn Connex? Spot Monitor; 901058 Vital Signs Monitor Core (CSM)

K241411 · Welch Allyn, Inc. · Cardiovascular

Dec 2024

Decision

217d

Days

Class 2

Risk

About This 510(k) Submission

K241411 is an FDA 510(k) clearance for the Welch Allyn Connex? Spot Monitor; 901058 Vital Signs Monitor Core (CSM), a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Welch Allyn, Inc. (Skaneateles Falls, US). The FDA issued a Cleared decision on December 20, 2024, 217 days after receiving the submission on May 17, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K241411 FDA.gov
FDA Decision	Cleared SESE
Date Received	May 17, 2024
Decision Date	December 20, 2024
Days to Decision	217 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF

Device Classification

Product Code	MWI — Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class	Class II — Special Controls
CFR Regulation	21 CFR 870.2300