Cleared Traditional

K894628 - MODEL DS-3300 DYNASCOPE PATIENT MONITOR

K894628 is the FDA 510(k) clearance for MODEL DS-3300 DYNASCOPE PATIENT MONITOR by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 168-day FDA review.

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
Combination Product No
PCCP Authorized No
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 231
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K894628.
ELATEC HOLTER ANALYZER
K895806 · Ela Medical, Inc. · Apr 1990
MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
K894543 · Del Mar Avionics · Feb 1990
FUKUDA DENSHI MODEL DS-3300 ETR
K897063 · Fukuda Denshi USA, Inc. · Feb 1990
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692 · Nihon Kohden America, Inc. · Oct 1989
SEER
K882818 · Marquette Electronics, Inc. · Jun 1989
MAX-1 (EXERCISE ELECTROCARDIOGRAPH)
K890323 · Marquette Electronics, Inc. · Jun 1989