Cleared Traditional

K190011 - Passport Series Patient Monitors (inclu...

K190011 is the FDA 510(k) clearance for Passport Series Patient Monitors (inclu... 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 188-day FDA review.

K190011 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Jul 2019
Decision
188d
Days
Class 2
Risk

K190011 is an FDA 510(k) clearance for the Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1). 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 July 10, 2019 after a review of 188 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 K190011 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 03, 2019
Decision Date July 10, 2019
Days to Decision 188 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
63d slower than avg
Panel avg: 125d · This submission: 188d
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 K190011.
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
ePM Series Patient monitors
K191769 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Oct 2019
M3290B Patient Information Center iX
K183387 · Philips Medical Systems · Aug 2019
North-vision Multi-parameter Patient Monitor
K173036 · North-Vision Tech., Inc. · Dec 2018
BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)
K182075 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Dec 2018
ZOLL Propaq M
K180482 · ZOLL Medical Corporation · Nov 2018