Cleared Traditional

K920743 - DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS

K920743 is an FDA 510(k) clearance for DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS, manufactured by Nihon Kohden America, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 202-day FDA review.

K920743 · Nihon Kohden America, Inc. · Cardiovascular device
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Sep 1992
Decision
202d
Days
Class 2
Risk

K920743 is an FDA 510(k) clearance for the DUAL LEAD (ECG1 & ECG2) ARRHYTHMIA ANALYSIS. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Nihon Kohden America, Inc. (Irvine, US). The FDA issued a Cleared decision on September 3, 1992 after a review of 202 days - an extended review cycle.

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. 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 Nihon Kohden America, Inc. devices

FDA 510(k) Submission Details - K920743

510(k) Number K920743 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 1992
Decision Date September 03, 1992
Days to Decision 202 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
77d slower than avg
Panel avg: 125d · This submission: 202d
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 238
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K920743.
SPACELABS MEDICAL PATIENT MONITOR
K930095 · Spacelabs Medical, Inc. · Sep 1993
CC ARHYTHMIS MONITORING OPTION
K923747 · Hewlett-Packard Co. · Jul 1993
BSM-8800A BEDSIDE MONITOR
K920154 · Nihon Kohden America, Inc. · Dec 1992
BSM-2100A CONFIGURED PATIENT MONITOR
K914092 · Nihon Kohden America, Inc. · May 1992
ZB-860PA MULTIPARAMETER TRANSMITTER
K913117 · Nihon Kohden America, Inc. · Apr 1992
ESCORT-LINK ARRHYTHMIA OPTION 23L
K915153 · Medical Data Electronics · Apr 1992