Cleared Traditional

CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH) (K863116) - FDA 510(k) Clearance

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

K863116 · Nihon Kohden America, Inc. · Cardiovascular device
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Sep 1986
Decision
34d
Days
Class 2
Risk

K863116 is an FDA 510(k) clearance for the CARDIOFAX ECG-6551 (ELECTROCARDIOGRPH). Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on September 17, 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 Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K863116 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 14, 1986
Decision Date September 17, 1986
Days to Decision 34 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
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.

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.

Regulatory Peers - DPS Electrocardiograph

All 122
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K863116.
ELECTROCARDIOGRAPH
K865031 · Nihon Kohden America, Inc. · Feb 1987
MINGOGRAF 410
K864009 · Siemens Medical Solutions USA, Inc. · Jan 1987
630C ELECTROCARDIOGRAPH
K863030 · Quinton, Inc. · Nov 1986
MODEL 43200A CARDIAC MONITOR
K861992 · Hewlett-Packard Co. · Jun 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · Hewlett-Packard Co. · May 1986
CARDIOFAX ECG-6353
K860212 · Nihon Kohden America, Inc. · Apr 1986