Cleared Traditional

FUKUDA DENSHI MODEL FCP-4101 (K913811) - FDA 510(k) Clearance

K913811 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Dec 1991
Decision
105d
Days
-
Risk

K913811 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL FCP-4101.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on December 9, 1991 after a review of 105 days - within the typical 510(k) review window.

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 K913811 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 26, 1991
Decision Date December 09, 1991
Days to Decision 105 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
20d faster than avg
Panel avg: 125d · This submission: 105d
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