Cleared Traditional

K823844 - HORIZON ECG SYSTEM

K823844 is an FDA 510(k) clearance for HORIZON ECG SYSTEM, manufactured by Beckman Instruments, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 751-day FDA review.

K823844 · Beckman Instruments, Inc. · Cardiovascular device
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Jan 1985
Decision
751d
Days
Class 2
Risk

K823844 is an FDA 510(k) clearance for the HORIZON ECG SYSTEM. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Beckman Instruments, Inc. (Fullerton, US). The FDA issued a Cleared decision on January 10, 1985 after a review of 751 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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Cardiovascular submissions.

View all Beckman Instruments, Inc. devices

FDA 510(k) Submission Details - K823844

510(k) Number K823844 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 21, 1982
Decision Date January 10, 1985
Days to Decision 751 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
626d slower than avg
Panel avg: 125d · This submission: 751d
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 234
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K823844.
SYSTEM SIRECUST 400 SIEMENS SIRECUST 456-1A
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ARRHYTHMIA SYSTEM AC-11
K841084 · Fukuda Denshi USA, Inc. · Feb 1985
SERVOMED ARRHYCOMP CENTRAL MONITOR SYS
K840899 · Litton Medical Electronics · Nov 1984
PEDIATRIC DIAG. CRITERIA OPTION 5600C
K841416 · Hewlett-Packard Co. · Oct 1984
SPACELABS ALPHA PC PATIENT COMPUTER
K842616 · Spacelabs, Inc. · Oct 1984