Cleared Traditional

MODEL DS-3300 DYNASCOPE PATIENT MONITOR (K894628) - FDA 510(k) Clearance

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

K894628 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Jan 1990
Decision
168d
Days
Class 2
Risk

K894628 is an FDA 510(k) clearance for the MODEL DS-3300 DYNASCOPE PATIENT 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 January 8, 1990 after a review of 168 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 K894628 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 24, 1989
Decision Date January 08, 1990
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. 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 K894628.
HEWLETT-PACKARD MODEL 78720AC ARRHYTHMIA MONIT SYS
K913451 · Hewlett-Packard Co. · Oct 1991
MODIFIED MONITORING SYSTEM MODELS M1175A & M1176A
K910490 · Hewlett-Packard Co. · Apr 1991
MODEL 43420B NEWWAVE HOLTER SYSTEM/MODIFICATION
K910291 · Hewlett-Packard Co. · Apr 1991
SUPERVISORY TELEMETRY ARRHYTHMIA TERMINAL
K884106 · Siemens Medical Solutions USA, Inc. · Mar 1989
MODEL 43400A REAL-TIME AMBULATORY ECG MONITOR ANAL
K853669 · Hewlett-Packard Co. · Mar 1986
MODEL 78560A CENTRAL STATION PATIENT INFO SYS
K852514 · Hewlett-Packard Co. · Sep 1985