Cleared Traditional

FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR (K970585) - FDA 510(k) Clearance

Class II Cardiovascular device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K970585 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 1997
Decision
207d
Days
Class 2
Risk

K970585 is an FDA 510(k) clearance for the FUKUDA DENSHI DYNASCOPE MODEL DS-5800 CENTRAL STATION MONITOR. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on September 9, 1997 after a review of 207 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

Submission Details

510(k) Number K970585 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1997
Decision Date September 09, 1997
Days to Decision 207 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
82d slower than avg
Panel avg: 125d · This submission: 207d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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 68
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K970585.
SIEMENS MULTIVIEW WORKSTATION ENHANCED WITH DIAGNOSTIC STATEMENTS (REST ECG)
K980625 · Siemens Medical Solutions USA, Inc. · May 1998
SIEMENS MULTIVIEW WORKSTATION INFINITY TELEMETRY SYSTEM
K972714 · Siemens Medical Solutions USA, Inc. · Oct 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K964624 · Siemens Medical Solutions USA, Inc. · Sep 1997
SIEMENS SC/9000/SC9015 SERIES SURGICAL DISPLAY CONTROLLER
K970348 · Siemens Medical Solutions USA, Inc. · Aug 1997
SIEMENS SC9000/SC9015 BEDSIDE MONITORING SYSTEM
K970920 · Siemens Medical Solutions USA, Inc. · Jul 1997
SIEMENS SC9000/SC9015 MULTIGAS AND MULTIGAS+ MODULES
K965062 · Siemens Medical Solutions USA, Inc. · Jun 1997