Cleared Traditional

K150082 - Panorama Patient Monitoring Network

K150082 is the FDA 510(k) clearance for Panorama Patient Monitoring Network 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 230-day FDA review.

K150082 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Sep 2015
Decision
230d
Days
Class 2
Risk

K150082 is an FDA 510(k) clearance for the Panorama Patient Monitoring Network. 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 September 2, 2015 after a review of 230 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 K150082 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 15, 2015
Decision Date September 02, 2015
Days to Decision 230 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
105d slower than avg
Panel avg: 125d · This submission: 230d
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 198
Devices cleared under the same product code (MHX) and FDA review panel - the closest regulatory comparables to K150082.
Passport Series Patient Monitors (Including Passport 8, Passport 12)
K153448 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Mar 2016
Passport Series Patient Monitors (including Passport 17m, Passport 12m and T1)
K152902 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Feb 2016
PATIENT MONITORS VARIOUS MODELS
K151812 · Philips Medical Systems · Jan 2016
V Series Monitoring System (including V12 and V21 Monitors)
K150352 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Sep 2015
IM60/IM70 PATIENT MONITOR
K131971 · Edan Instruments, Inc. · Mar 2014
PHILIPS SURESIGNS CENTRAL
K131032 · Philips Medical Systems · Aug 2013