Cleared Traditional

K240320 - Patient Monitor (RespArray) (FDA 510(k) Clearance)

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

K240320 · Edan Instruments, Inc. · Cardiovascular device

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Jun 2024

Decision

147d

Days

Class 2

Risk

K240320 is an FDA 510(k) clearance for the Patient Monitor (RespArray). Classified as Monitor, Physiological, Patient(with Arrhythmia Detection Or Alarms) (product code MHX), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on June 28, 2024 after a review of 147 days - within the typical 510(k) review window.

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 Edan Instruments, Inc. devices

Submission Details

510(k) Number	K240320 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	February 02, 2024
Decision Date	June 28, 2024
Days to Decision	147 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

22d slower than avg

Panel avg: 125d · This submission: 147d

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.