Cleared Traditional

K897063 - FUKUDA DENSHI MODEL DS-3300 ETR

K897063 is the FDA 510(k) clearance for FUKUDA DENSHI MODEL DS-3300 ETR by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 43-day FDA review.

K897063 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Feb 1990
Decision
43d
Days
Class 2
Risk

K897063 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL DS-3300 ETR. 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 February 1, 1990 after a review of 43 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fukuda Denshi USA, Inc. devices

Submission Details

510(k) Number K897063 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 20, 1989
Decision Date February 01, 1990
Days to Decision 43 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
82d faster than avg
Panel avg: 125d · This submission: 43d
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 K897063.
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MODEL 493 SSR-3 THREE CHANNEL SOLID-STATE RECORDER
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SEER
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