Cleared Traditional

K151787 - Holter System

K151787 is the FDA 510(k) clearance for Holter System by Edan Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DQK) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K151787 · Edan Instruments, Inc. · Cardiovascular device
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Jan 2016
Decision
210d
Days
Class 2
Risk

K151787 is an FDA 510(k) clearance for the Holter System. Classified as Computer, Diagnostic, Programmable (product code DQK), Class II - Special Controls.

Submitted by Edan Instruments, Inc. (Shenzhen, CN). The FDA issued a Cleared decision on January 27, 2016 after a review of 210 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1425 - 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 K151787 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 01, 2015
Decision Date January 27, 2016
Days to Decision 210 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
85d slower than avg
Panel avg: 125d · This submission: 210d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DQK Computer, Diagnostic, Programmable
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1425
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 Consultant

Edan Medical
DOUG WORTH

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - DQK Computer, Diagnostic, Programmable

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