Cleared Traditional

Central Station

K242750 · Nihon Kohden Digital Health Solutions, LLC · Cardiovascular

Jun 2025

Decision

266d

Days

Class 2

Risk

About This 510(k) Submission

K242750 is an FDA 510(k) clearance for the Central Station, a System, Network And Communication, Physiological Monitors (Class II — Special Controls, product code MSX), submitted by Nihon Kohden Digital Health Solutions, LLC (Irvine, US). The FDA issued a Cleared decision on June 5, 2025, 266 days after receiving the submission on September 12, 2024. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.2300.

Submission Details

510(k) Number	K242750 FDA.gov
FDA Decision	Cleared SESE
Date Received	September 12, 2024
Decision Date	June 05, 2025
Days to Decision	266 days
Submission Type	Traditional
Review Panel	Cardiovascular (CV)
Summary	Summary PDF