Cleared Traditional

CARDIOFAX Q ECG-8420A (K922394) - FDA 510(k) Clearance

K922394 · Nihon Kohden America, Inc. · Cardiovascular device
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Mar 1994
Decision
650d
Days
-
Risk

K922394 is an FDA 510(k) clearance for the CARDIOFAX Q ECG-8420A.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on March 1, 1994 after a review of 650 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Nihon Kohden America, Inc. devices

Submission Details

510(k) Number K922394 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 1992
Decision Date March 01, 1994
Days to Decision 650 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
525d slower than avg
Panel avg: 125d · This submission: 650d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 14
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