Cleared Traditional

Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15)

K250179 · Edan Instruments, Inc. · Cardiovascular
Jul 2025
Decision
188d
Days
Class 2
Risk

About This 510(k) Submission

K250179 is an FDA 510(k) clearance for the Patient Monitor (CX10, CX12, CX15, UX10, UX12, UX15), a Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (Class II — Special Controls, product code MHX), submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on July 29, 2025, 188 days after receiving the submission on January 22, 2025. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1025.

Submission Details

510(k) Number K250179 FDA.gov
FDA Decision Cleared SESE
Date Received January 22, 2025
Decision Date July 29, 2025
Days to Decision 188 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF

Device Classification

Product Code MHX — Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1025

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