Cleared Traditional

K211475 - Vital Signs Monitors

K211475 is the FDA 510(k) clearance for Vital Signs Monitors by Shenzhen Mindray Bio-Medical Electronics Co., Ltd.. It is a Class 2 Cardiovascular device (product code MWI) cleared through the Traditional 510(k) pathway after a 146-day FDA review.

K211475 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device
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Oct 2021
Decision
146d
Days
Class 2
Risk

K211475 is an FDA 510(k) clearance for the Vital Signs Monitors. Classified as Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms) (product code MWI), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on October 5, 2021 after a review of 146 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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 K211475 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 12, 2021
Decision Date October 05, 2021
Days to Decision 146 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
21d slower than avg
Panel avg: 125d · This submission: 146d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - MWI Monitor, Physiological, Patient (without Arrhythmia Detection Or Alarms)

All 123
Devices cleared under the same product code (MWI) and FDA review panel - the closest regulatory comparables to K211475.
Capsule Surveillance System
K213335 · Capsule Surveillance Technologies, Sas /Capsule Tech, Inc. · Jan 2022
Vital Signs Monitor
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Philips MR Patient Care Portal
K212227 · Invivo Corporation · Sep 2021
Vitals360 Multi-Vitals Mobile Monitor
K210086 · Vocare, Inc. · May 2021
ZOLL Propaq M
K202375 · ZOLL Medical Corporation · Mar 2021