Cleared Traditional

K191769 - ePM Series Patient monitors

K191769 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 122-day FDA review.

K191769 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Oct 2019
Decision
122d
Days
Class 2
Risk

K191769 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 October 31, 2019 after a review of 122 days - within the typical 510(k) review window.

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 K191769 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2019
Decision Date October 31, 2019
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
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 K191769.
ZOLL Arrhythmia Management Sysyem
K190939 · Zoll Manufacturing Corporation · Dec 2019
C50 and C80 Multi-parameter Patient Monitor
K191106 · Shenzhen Comen Medical Instruments Co.,Ltd · Dec 2019
IntelliVue Patient Monitors MX100, MX400, MX430, MX450, MX500, MX550, IntelliVue Patient Monitors MX700, MX800, IntelliVue Patient Monitors MP5, MP5SC, Multi-Measurement Module X3
K182979 · Philips Medizin Systeme Boeblingen GmbH · Nov 2019
M3290B Patient Information Center iX
K183387 · Philips Medical Systems · Aug 2019
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K190011 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Jul 2019
North-vision Multi-parameter Patient Monitor
K173036 · North-Vision Tech., Inc. · Dec 2018