Cleared Traditional

WARD-CSS (v1.2.x)

K241958 · Ward 24/7 Aps · Cardiovascular

Feb 2025

Decision

226d

Days

Class 2

Risk

About This 510(k) Submission

K241958 is an FDA 510(k) clearance for the WARD-CSS (v1.2.x), a Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MWI), submitted by Ward 24/7 Aps (Copenhagen, DK). The FDA issued a Cleared decision on February 14, 2025, 226 days after receiving the submission on July 3, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K241958 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 03, 2024
Decision Date	February 14, 2025
Days to Decision	226 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