Cleared Traditional

K822030 - MULTIPLE LEAD ARRHYTHMIA MODULE

K822030 is an FDA 510(k) clearance for MULTIPLE LEAD ARRHYTHMIA MODULE, manufactured by Marquette Electronics, Inc.. The device is a Class 2 Cardiovascular device with product code DSI cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K822030 · Marquette Electronics, Inc. · Cardiovascular device
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Sep 1982
Decision
78d
Days
Class 2
Risk

K822030 is an FDA 510(k) clearance for the MULTIPLE LEAD ARRHYTHMIA MODULE. Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Mchenry, US). The FDA issued a Cleared decision on September 28, 1982 after a review of 78 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K822030

510(k) Number K822030 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 12, 1982
Decision Date September 28, 1982
Days to Decision 78 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
47d faster than avg
Panel avg: 125d · This submission: 78d
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 305
Devices cleared under the same product code (DSI) and FDA review panel - the closest regulatory comparables to K822030.
EPI CARDIA SYS. - AMBULATORY MONITOR
K830013 · Medicomp, Inc. · Feb 1983
LS6 ARRYTHMIA DISCRIMINATOR
K822616 · Life Science Instrumentation, Inc. · Oct 1982
SERIES 7000 BEDSIDE PATIENT MONITOR
K822718 · Marquette Electronics, Inc. · Oct 1982
MEMOPORT C
K820881 · Litton Medical Electronics · May 1982
QUINTON Q2000 ETT MONITORING SYSTEM
K820438 · Quinton, Inc. · Apr 1982
ALGORITHM OF THE ARRHYTHMIA MON. SYS
K820477 · Hewlett-Packard Co. · Apr 1982