Cleared Traditional

K862544 - KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH

K862544 is an FDA 510(k) clearance for KENZ-ECG-102 SINGLE CHANNEL ELECTROCARD..., 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 34-day FDA review.

K862544 · Suzuken Co., Ltd. · Cardiovascular device
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Aug 1986
Decision
34d
Days
Class 2
Risk

K862544 is an FDA 510(k) clearance for the KENZ-ECG-102 SINGLE CHANNEL ELECTROCARDIOGRAPH. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Suzuken Co., Ltd. (Indianapolis, US). The FDA issued a Cleared decision on August 6, 1986 after a review of 34 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Suzuken Co., Ltd. devices

FDA 510(k) Submission Details - K862544

510(k) Number K862544 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 03, 1986
Decision Date August 06, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
91d faster than avg
Panel avg: 125d · This submission: 34d
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 332
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K862544.
CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH)
K863116 · Nihon Kohden America, Inc. · Sep 1986
BURDICK DIVISION (E-500)
K861850 · Mortara Instrument, Inc. · Aug 1986
SIEMENS-ELEMA (SICARD-P)
K861851 · Mortara Instrument, Inc. · Aug 1986
FUTUREMED ECG SYSTEM 500
K862381 · Futuremed Div. of Future Impex Corp. · Jul 1986
SIEMENS SIRECUST MODELS 403P,403-2P & 403N
K855096 · Analogic Corp. · Jul 1986
MODEL 43200A CARDIAC MONITOR
K861992 · Hewlett-Packard Co. · Jun 1986