Cleared Traditional

CARDIOFAX-V ECG-834OA (K865032) - FDA 510(k) Clearance

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

K865032 · Nihon Kohden America, Inc. · Cardiovascular device
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Mar 1987
Decision
77d
Days
Class 2
Risk

K865032 is an FDA 510(k) clearance for the CARDIOFAX-V ECG-834OA. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on March 10, 1987 after a review of 77 days - a notably fast clearance cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.1025 - 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 K865032 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 23, 1986
Decision Date March 10, 1987
Days to Decision 77 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
48d faster than avg
Panel avg: 125d · This submission: 77d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DSI Detector And Alarm, Arrhythmia
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.1025
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 - DSI Detector And Alarm, Arrhythmia

All 98
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K865032.
CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · Nihon Kohden America, Inc. · Sep 1987
CARDIOFAX-V ECG-8240A
K865030 · Nihon Kohden America, Inc. · Mar 1987
Q-SCAN II AND Q-SCAN III
K864149 · Quinton, Inc. · Dec 1986
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159 · Quinton, Inc. · Oct 1986
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · Hewlett-Packard Co. · Mar 1986