Cleared Traditional

K213799 - N Series Patient Monitors

K213799 is the FDA 510(k) clearance for N 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 218-day FDA review.

K213799 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2022
Decision
218d
Days
Class 2
Risk

K213799 is an FDA 510(k) clearance for the N 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 July 12, 2022 after a review of 218 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 K213799 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 2021
Decision Date July 12, 2022
Days to Decision 218 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
93d slower than avg
Panel avg: 125d · This submission: 218d
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 K213799.
Patient Monitor, models LM-8, LM-10, LM-12 and LM-15
K221879 · Caf Medical Solutions, Inc. · Aug 2022
Patient Monitor, models LMPLUS-12, LMPLUS-15 and LMPLUS-17
K221616 · Caf Medical Solutions, Inc. · Aug 2022
Next Generation NetKonnect
K220989 · Nihon Kohden Digital Health Solutions, Inc. · Jul 2022
CARESCAPE B650, E-musb
K213181 · GE Healthcare Finland Oy · Apr 2022
Carescape B850, E-musb
K213336 · GE Healthcare Finland Oy · Apr 2022
CARESCAPE B450, E-musb
K213363 · GE Healthcare Finland Oy · Apr 2022