Cleared Traditional

K001896 - KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS (FDA 510(k) Clearance)

Also includes:
KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC

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

K001896 · Suzuken Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jan 2001
Decision
201d
Days
Class 2
Risk

K001896 is an FDA 510(k) clearance for the KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Suzuken Co., Ltd. (Great Neck, US). The FDA issued a Cleared decision on January 8, 2001 after a review of 201 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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 Suzuken Co., Ltd. devices

Submission Details

510(k) Number K001896 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2000
Decision Date January 08, 2001
Days to Decision 201 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 125d · This submission: 201d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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.

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