Cleared Traditional

K890323 - MAX-1 (EXERCISE ELECTROCARDIOGRAPH)

K890323 is an FDA 510(k) clearance for MAX-1 (EXERCISE ELECTROCARDIOGRAPH), 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 144-day FDA review.

K890323 · Marquette Electronics, Inc. · Cardiovascular device
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Jun 1989
Decision
144d
Days
Class 2
Risk

K890323 is an FDA 510(k) clearance for the MAX-1 (EXERCISE ELECTROCARDIOGRAPH). Classified as Detector And Alarm, Arrhythmia (product code DSI), Class II - Special Controls.

Submitted by Marquette Electronics, Inc. (Milwaukee, US). The FDA issued a Cleared decision on June 16, 1989 after a review of 144 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: 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K890323

510(k) Number K890323 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 23, 1989
Decision Date June 16, 1989
Days to Decision 144 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
19d slower than avg
Panel avg: 125d · This submission: 144d
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 K890323.
1100 VITAL SIGNS MONITOR
K884643 · Criticare Systems, Inc. · Oct 1989
BEDSIDE MONITORS, BSM-8301A, BSM-8302A
K894692 · Nihon Kohden America, Inc. · Oct 1989
SEER
K882818 · Marquette Electronics, Inc. · Jun 1989
MODEL 152 DELTA HOLTER ECG ANALYSIS SYSTEM
K891148 · Del Mar Avionics · May 1989
MEDILOG 6000-FD REPORT GENERATOR
K890330 · Oxford Medilog, Inc. · Apr 1989
HORIZON 2000 ARRHYTHMIA MONITOR OPTION - (ALARMS)
K885204 · Mennen Medical, Inc. · Apr 1989