Cleared Traditional

K001896 - KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS

Also marketed or referenced as:
KENZ ECG 110 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS WITH EC

K001896 is an FDA 510(k) clearance for KENZ ECG 108 SINGLE CHANNEL DIGITAL ELE..., manufactured by Suzuken Co., Ltd.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 201-day FDA review.

K001896 · Suzuken Co., Ltd. · Cardiovascular device
Download Printable Device Report (PDF) Official FDA 510(k) Summary (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.

FDA 510(k) Submission Details - K001896

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
Combination Product No
PCCP Authorized No
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.

DPS Device Classification - Class 2, Special Controls

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.

Regulatory Peers - DPS Electrocardiograph

All 492
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K001896.
TELEMED 12 LEAD RESTING ECG ANALYSIS LIBRARY
K010505 · Brentwood Medical Technology Corp. · Mar 2001
VERTEX SYSTEM
K002822 · Medical Positioning, Inc. · Jan 2001
CARDIO MONITOR CENTER VISION
K003392 · Shl Telemedicine International , Ltd. · Jan 2001
CARTOUCH
K002197 · Cardionics, Inc. · Dec 2000
PAGEWRITER 10/10I, MODEL M2662A HANDHELD ELECTROCARDIOGRAPH
K002459 · Agilent Technologies, Inc. · Nov 2000
WEC-7101A POCKET SIZE ECG MONITOR AND ACCESSORIES
K002473 · Nihon Kohden America, Inc. · Nov 2000
K001896 · KENZ ECG 108 SINGLE CHANNEL DIGITAL ELECTROCARDIOGRAPHS
Download PDF FDA Summary Suzuken Co., Ltd.