Cleared Traditional

K841084 - ARRHYTHMIA SYSTEM AC-11

K841084 is an FDA 510(k) clearance for ARRHYTHMIA SYSTEM AC-11, manufactured by Fukuda Denshi USA, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 325-day FDA review.

K841084 · Fukuda Denshi USA, Inc. · Cardiovascular device
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Feb 1985
Decision
325d
Days
Class 2
Risk

K841084 is an FDA 510(k) clearance for the ARRHYTHMIA SYSTEM AC-11. 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 February 1, 1985 after a review of 325 days - an unusually long review period, suggesting complex equivalence evaluation.

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: Standard predicate-based submission. Elevated predicate reliance profile. 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

FDA 510(k) Submission Details - K841084

510(k) Number K841084 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 13, 1984
Decision Date February 01, 1985
Days to Decision 325 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
200d slower than avg
Panel avg: 125d · This submission: 325d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

DSI Device Classification - Class 2, Special Controls

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 299
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K841084.
SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A
K844791 · Analogic Corp. · Apr 1985
FUKUDA DENSHI DS-1020A & DS-1040A DYNASCOPY SERIES
K850897 · Fukuda Denshi USA, Inc. · Apr 1985
BRENTWOOD EZ SCAN 200 AMBULATORY ECG
K842976 · Brentwood Instruments, Inc. · Mar 1985
HORIZON ECG SYSTEM
K823844 · Beckman Instruments, Inc. · Jan 1985
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
K840899 · Litton Medical Electronics · Nov 1984
EPICARDIA, PC
K843513 · Medicomp, Inc. · Oct 1984