Cleared Traditional

K860212 - CARDIOFAX ECG-6353

K860212 is an FDA 510(k) clearance for CARDIOFAX ECG-6353, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 85-day FDA review.

K860212 · Nihon Kohden America, Inc. · Cardiovascular device
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Apr 1986
Decision
85d
Days
Class 2
Risk

K860212 is an FDA 510(k) clearance for the CARDIOFAX ECG-6353. 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 April 17, 1986 after a review of 85 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

FDA 510(k) Submission Details - K860212

510(k) Number K860212 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 22, 1986
Decision Date April 17, 1986
Days to Decision 85 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
40d faster than avg
Panel avg: 125d · This submission: 85d
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 279
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K860212.
MODEL 43200A CARDIAC MONITOR
K861992 · Hewlett-Packard Co. · Jun 1986
CARDIAC MONITOR, CARDIOTACHOMETER AND ALARM
K861359 · Hewlett-Packard Co. · May 1986
PHYSIOLOGICAL MONITOR, MODELS 101,301,201,202,303A
K854840 · Ivy Biomedical Systems, Inc. · May 1986
ESCORT ECG MONITOR SIEMENS SIRECUST 466
K854234 · Medical Data Electronics · Jan 1986
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
CARDIOSTAT 3 RECORDER
K851044 · Siemens Elema AB · Jun 1985