Cleared Traditional

K844470 - FUKUDA DENSHI MODEL FCP-220

K844470 is an FDA 510(k) clearance for FUKUDA DENSHI MODEL FCP-220, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DPS cleared through the Traditional 510(k) pathway after a 52-day FDA review.

K844470 · Brentwood Instruments, Inc. · Cardiovascular device
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Jan 1985
Decision
52d
Days
Class 2
Risk

K844470 is an FDA 510(k) clearance for the FUKUDA DENSHI MODEL FCP-220. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Torrance, US). The FDA issued a Cleared decision on January 10, 1985 after a review of 52 days - a notably fast clearance cycle.

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: 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 Brentwood Instruments, Inc. devices

FDA 510(k) Submission Details - K844470

510(k) Number K844470 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1984
Decision Date January 10, 1985
Days to Decision 52 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
73d faster than avg
Panel avg: 125d · This submission: 52d
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 330
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K844470.
MONITORING SYSTEM M720
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SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985
CARDIO IV/GXT STRESS TESTING SYSTEM
K844744 · Intl. Medical, Inc. · Jan 1985
FITNESS LOGGER
K840020 · Britt Corp., Inc. · Oct 1984
ELECTROCARDIOGRAPH E-340
K840440 · Burdick Corp. · Aug 1984
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984