Cleared Traditional

K230184 - Holter ECG and ABP System (FDA 510(k) Clearance)

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

K230184 · Edan Instruments, Inc. · Cardiovascular device

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Sep 2023

Decision

245d

Days

Class 2

Risk

K230184 is an FDA 510(k) clearance for the Holter ECG and ABP System. Classified as Recorder, Magnetic Tape, Medical (product code DSH), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on September 25, 2023 after a review of 245 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2800 - 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	K230184 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	January 23, 2023
Decision Date	September 25, 2023
Days to Decision	245 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

120d slower than avg

Panel avg: 125d · This submission: 245d

Pathway characteristics

Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code	DSH Recorder, Magnetic Tape, Medical
Device Class	Class 2 - Special Controls
CFR Regulation	21 CFR 870.2800

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.