Cleared Traditional

K200015 - ePM Series Patient monitors

K200015 is the FDA 510(k) clearance for ePM Series Patient monitors by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Cardiovascular device (product code MHX) cleared through the Traditional 510(k) pathway after a 157-day FDA review.

K200015 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Jun 2020
Decision
157d
Days
Class 2
Risk

K200015 is an FDA 510(k) clearance for the ePM Series Patient monitors. Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on June 8, 2020 after a review of 157 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - the FDA cardiovascular device oversight framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Shenzhen Mindray Bio-Medical Electronics Co., Ltd. devices

Submission Details

510(k) Number K200015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2020
Decision Date June 08, 2020
Days to Decision 157 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 125d · This submission: 157d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Cardiovascular devices follow this clearance model.

Regulatory Peers - MHX Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms)

All 275
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K200015.
Tempus Pro Patient Monitor
K201746 · Remote Diagnostic Technologies Limited · Sep 2020
IntelliVue Patient Monitor MX500, IntelliVue Patient Monitor MX550
K192137 · Philips Medizin Systeme Boeblingen GmbH · Sep 2020
Infinity M300
K200859 · Draeger Medical Systems, Inc. · Aug 2020
Patient Monitor
K192972 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · May 2020
Patient Monitor
K192514 · Edan Instruments, Inc. · Apr 2020
CARESCAPE ONE and CARESCAPE DOCK FO, CARESCAPE ECG, CARESCAPE TEMP, CARESCAPE PRES
K200494 · Ge Healthcare · Mar 2020