Cleared Traditional

K833593 - FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN

K833593 is the FDA 510(k) clearance for FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN by Brentwood Instruments, Inc.. It is a Class 2 Cardiovascular device (product code DPS) cleared through the Traditional 510(k) pathway after a 210-day FDA review.

K833593 · Brentwood Instruments, Inc. · Cardiovascular device
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May 1984
Decision
210d
Days
Class 2
Risk

K833593 is an FDA 510(k) clearance for the FUKUDA DENSHI FX-102 AUTO-SINGLE CHAN. Classified as Electrocardiograph (product code DPS), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on May 9, 1984 after a review of 210 days - an extended review 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: 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 Brentwood Instruments, Inc. devices

Submission Details

510(k) Number K833593 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 12, 1983
Decision Date May 09, 1984
Days to Decision 210 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary -
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
85d slower than avg
Panel avg: 125d · This submission: 210d
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 172
Devices cleared under the same product code (DPS) and FDA review panel - the closest regulatory comparables to K833593.
VSM-5
K852322 · Physio-Control Corp. · Sep 1985
SURGICAL MODULE 7000 ECG
K840869 · Marquette Electronics, Inc. · Feb 1985
QUINTON 901 & 900 HOLTER SCANNER
K841611 · Quinton, Inc. · Aug 1984
VITAL SIGNS MONITOR 3
K833584 · Physio-Control Corp. · Jan 1984
CASE-II
K833458 · Marquette Electronics, Inc. · Nov 1983
PACEMAKER EVALUATION MODULE-330
K833470 · Marquette Electronics, Inc. · Nov 1983