Cleared Traditional

K242728 - BeneVision Central Monitoring System (FDA 510(k) Clearance)

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K242728 · Shenzhen Mindray Bio-Medical Electronics Co., Ltd. · Cardiovascular device

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Jul 2025

Decision

324d

Days

Class 2

Risk

K242728 is an FDA 510(k) clearance for the BeneVision Central Monitoring System. Classified as System, Network And Communication, Physiological Monitors (product code MSX), Class II - Special Controls.

Submitted by Shenzhen Mindray Bio-Medical Electronics Co., Ltd. (Shenzhen, CN). The FDA issued a Cleared decision on July 31, 2025 after a review of 324 days - an unusually long review period, suggesting complex equivalence evaluation.

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. Elevated predicate reliance profile. 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	K242728 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	September 10, 2024
Decision Date	July 31, 2025
Days to Decision	324 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

199d slower than avg

Panel avg: 125d · This submission: 324d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	MSX System, Network And Communication, Physiological Monitors
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.