Cleared Traditional

FUKUDA DENSHI MODEL FCP-2201 (K892796) - FDA 510(k) Clearance

K892796 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Oct 1989
Decision
168d
Days
-
Risk

K892796 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL FCP-2201.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on October 2, 1989 after a review of 168 days - an extended review cycle.

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: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Cardiovascular review framework, consistent with the majority of Class II 510(k) submissions.

View all Fukuda Denshi USA, Inc. devices

Submission Details

510(k) Number K892796 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 17, 1989
Decision Date October 02, 1989
Days to Decision 168 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
43d slower than avg
Panel avg: 125d · This submission: 168d
Pathway characteristics
Predicate-based equivalence.

Device Classification

Product Code LOS
Device Class -

Regulatory Peers - LOS

All 9
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N-CHANNEL
K834212 · Philips Medical Systems (Cleveland), Inc. · Nov 1984