Cleared Traditional

K893405 - MODEL DS-504 DYNASCOPE PATIENT MONITOR

K893405 is the FDA 510(k) clearance for MODEL DS-504 DYNASCOPE PATIENT MONITOR by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DRT) cleared through the Traditional 510(k) pathway after a 153-day FDA review.

K893405 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Oct 1989
Decision
153d
Days
Class 2
Risk

K893405 is an FDA 510(k) clearance for the MODEL DS-504 DYNASCOPE PATIENT MONITOR. Classified as Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm) (product code DRT), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on October 2, 1989 after a review of 153 days - an extended review cycle.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2300 - 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

Submission Details

510(k) Number K893405 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 02, 1989
Decision Date October 02, 1989
Days to Decision 153 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
28d slower than avg
Panel avg: 125d · This submission: 153d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2300
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 - DRT Monitor, Cardiac (incl. Cardiotachometer & Rate Alarm)

All 152
Devices cleared under the same product code (DRT) and FDA review panel - the closest regulatory comparables to K893405.
MAC-LAB CARDIAC CATHETERIZATION LABORATORY SYSTEM
K895801 · Marquette Electronics, Inc. · Apr 1990
CARDIOCAP(TM) CT-104 MONITOR
K897080 · Datex Division Instrumentarium Corp. · Mar 1990
ERGOMED 840/ERGOMED 840L
K885085 · Burdick Corp. · Oct 1989
TYPE 9140 (SYSTEM ATHENA)
K894699 · S & W Medico Teknik · Oct 1989
TYPE PDU/CDU 9040 (SYSTEM ATHENA)
K894700 · S & W Medico Teknik · Oct 1989
HORIZON CENTRAL STATION
K892066 · Mennen Medical, Inc. · Jun 1989