Cleared Traditional

K874768 - FUKUDA DENSHI MODEL FCP-231

K874768 is the FDA 510(k) clearance for FUKUDA DENSHI MODEL FCP-231 by Fukuda Denshi USA, Inc.. It is a Class 2 Cardiovascular device (product code DSI) cleared through the Traditional 510(k) pathway after a 29-day FDA review.

K874768 · Fukuda Denshi USA, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Dec 1987
Decision
29d
Days
Class 2
Risk

K874768 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL FCP-231. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Fukuda Denshi USA, Inc. (Kirkland, US). The FDA issued a Cleared decision on December 18, 1987 after a review of 29 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 K874768 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1987
Decision Date December 18, 1987
Days to Decision 29 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
96d faster than avg
Panel avg: 125d · This submission: 29d
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 K874768.
MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
K880664 · Mortara Instrument, Inc. · Mar 1988
KONTRON STRESSDATA STRESS DATA MANAGEMENT SYSTEM
K870816 · Kontron Instruments, Inc. · Mar 1988
CARDIOFAX-V ECG-8110A
K873874 · Nihon Kohden America, Inc. · Jan 1988
MODEL 6000FD AMBULATORY ECG ANALYSIS SYSTEM
K873680 · Oxford Medilog, Inc. · Nov 1987
MODEL MR-45 AMBULATORY HOLTER MONITOR
K872497 · Oxford Medilog, Inc. · Oct 1987
LIFESCOPE 12, BSM 8500A PATIENT MONITOR
K872241 · Nihon Kohden America, Inc. · Sep 1987