Cleared Traditional

K901817 - FUKUDA DENSHI MODEL FX-3101

K901817 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL FX-3101, manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 122-day FDA review.

K901817 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Aug 1990
Decision
122d
Days
Class 2
Risk

K901817 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL FX-3101. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Redmond, US). The FDA issued a Cleared decision on August 23, 1990 after a review of 122 days - within the typical 510(k) review window.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.2340 - 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.

FDA 510(k) Submission Details - K901817

510(k) Number K901817 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received April 23, 1990
Decision Date August 23, 1990
Days to Decision 122 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
3d faster than avg
Panel avg: 125d · This submission: 122d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DPS Device Classification - Class 2, Special Controls

Product Code DPS Electrocardiograph
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 870.2340
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 - DPS Electrocardiograph

All 579
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K901817.
CARDIOFAX ECG-8830A
K904758 · Nihon Kohden America, Inc. · Dec 1990
MICROMED QRS CARD
K903722 · Nasiff Assoc., Inc. · Dec 1990
PERSONAL 120/210 BASIC ELECTROCARDIOGRAPH
K902368 · Esaote Biomedica Spa · Sep 1990
CARDISUNY 501AB
K901947 · Graham-Field, Inc. · Jul 1990
CARDISUNY 501BIII
K901948 · Graham-Field, Inc. · Jul 1990
SIEMENS SIRECUST 732, PATIENT MONITOR
K901771 · Siemens Medical Electronics · May 1990
K901817 · FUKUDA DENSHI MODEL FX-3101
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