Cleared Traditional

K230184 - Holter ECG and ABP System

K230184 is the FDA 510(k) clearance for Holter ECG and ABP System by Edan Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DSH) cleared through the Traditional 510(k) pathway after a 245-day FDA review.

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.

Regulatory Peers - DSH Recorder, Magnetic Tape, Medical

All 72
Devices cleared under the same product code (DSH) and FDA review panel - the closest regulatory comparables to K230184.
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