Cleared Traditional

K964187 - FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR

K964187 is an FDA 510(k) clearance for FUKADA DENSHI DYNASCOPE MODEL DS-5300 P..., manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 192-day FDA review.

K964187 · Fukuda Denshi USA, Inc. · Cardiovascular device
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May 1997
Decision
192d
Days
Class 2
Risk

K964187 is an FDA 510(k) clearance for the FUKADA DENSHI DYNASCOPE MODEL DS-5300 PATIENT MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Great Neck,, US). The FDA issued a Cleared decision on May 1, 1997 after a review of 192 days - an extended review 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: 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

FDA 510(k) Submission Details - K964187

510(k) Number K964187 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 21, 1996
Decision Date May 01, 1997
Days to Decision 192 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
67d slower than avg
Panel avg: 125d · This submission: 192d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 299
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