Cleared Traditional

FUKUDA DENSHI MODEL FX-3101 (K901817) - FDA 510(k) Clearance

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

K901817 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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.

View all Fukuda Denshi USA, Inc. devices

Submission Details

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
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.

Device Classification

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 81
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K901817.
HEWLETT-PACKARD MODEL M1264B CATHSTATION
K952173 · Hewlett-Packard Co. · Aug 1995
HP M1175A, M1176A, COMPONENT MONITORING SYSTEM
K941811 · Hewlett-Packard Co. · May 1994
MEDTRONIC MODEL 9455 TELETRACE III ECG MONIT SYST
K914974 · Medtronic Vascular · Dec 1991
MODEL 78534C MONITOR/TERMINAL W/OPTIONS A03
K870380 · Hewlett-Packard Co. · Mar 1987
MINGOGRAF 410
K864009 · Siemens Medical Solutions USA, Inc. · Jan 1987
MODEL 43200A CARDIAC MONITOR
K861992 · Hewlett-Packard Co. · Jun 1986