Cleared Traditional

K823586 - COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200

K823586 is an FDA 510(k) clearance for COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200, manufactured by Brentwood Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 121-day FDA review.

K823586 · Brentwood Instruments, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Apr 1983
Decision
121d
Days
Class 2
Risk

K823586 is an FDA 510(k) clearance for the COMPUTER-AIDED ELECTROCARDIOGRAPH FCP200. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Brentwood Instruments, Inc. (Mchenry, US). The FDA issued a Cleared decision on April 6, 1983 after a review of 121 days - within the typical 510(k) review window.

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: Incremental AI imaging tool. Moderate equivalence dependency. Overall, this clearance reflects a predicate-aligned approval typical of modern AI radiology extensions - not a novel clinical breakthrough, but a validated iteration within an established regulatory category.

View all Brentwood Instruments, Inc. devices

FDA 510(k) Submission Details - K823586

510(k) Number K823586 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 06, 1982
Decision Date April 06, 1983
Days to Decision 121 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
4d faster than avg
Panel avg: 125d · This submission: 121d
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 270
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K823586.
ARRHYTHMIA III CARDULE #1919
K832693 · Spacelabs, Inc. · Nov 1983
WLECTROCARDIOGRAPH ECG-7204
K831274 · Nihon Kohden America, Inc. · Oct 1983
COMPUTER-AIDED ELECTROCARDIOGRAPH FCP-13
K823585 · Brentwood Instruments, Inc. · Apr 1983
SIRECUST 400
K830029 · Analogic Corp. · Mar 1983
HEARTRATE PLUS ECG CARDULE #1918
K830306 · Spacelabs, Inc. · Mar 1983
EPI CARDIA SYS. - AMBULATORY MONITOR
K830013 · Medicomp, Inc. · Feb 1983