Cleared Traditional

K903514 - FUKUDA DENSHI MODEL LX-3100

K903514 is the FDA 510(k) clearance for FUKUDA DENSHI MODEL LX-3100 by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 180-day FDA review.

K903514 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Jan 1991
Decision
180d
Days
Class 2
Risk

K903514 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL LX-3100. 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 30, 1991 after a review of 180 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 K903514 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 03, 1990
Decision Date January 30, 1991
Days to Decision 180 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
55d slower than avg
Panel avg: 125d · This submission: 180d
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 K903514.
ARRHYTHMIA 9215
K900366 · S & W Medico Teknik · Apr 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
MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
K900720 · Mortara Instrument, Inc. · Nov 1990
FUKUDA DENSHI MODEL FCP-2201 MODIFICATION
K903704 · Fukuda Denshi USA, Inc. · Sep 1990
TRAM PATIENT MONITOR
K900540 · Marquette Electronics, Inc. · Jul 1990