Cleared Traditional

K862316 - CASE 12

K862316 is an FDA 510(k) clearance for CASE 12, 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 155-day FDA review.

K862316 · Marquette Electronics, Inc. · Cardiovascular device
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Nov 1986
Decision
155d
Days
Class 2
Risk

K862316 is an FDA 510(k) clearance for the CASE 12. 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 November 20, 1986 after a review of 155 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 Marquette Electronics, Inc. devices

FDA 510(k) Submission Details - K862316

510(k) Number K862316 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 18, 1986
Decision Date November 20, 1986
Days to Decision 155 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
30d slower than avg
Panel avg: 125d · This submission: 155d
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 K862316.
EPICARDIA, PC/FD
K863643 · Medicomp, Inc. · Dec 1986
SPACELABS - ARRHYTHMIA NET (TM) LEVEL 1
K864506 · Spacelabs, Inc. · Nov 1986
SPACELABS ARRHYTHMIA NET (TM) LEVEL 2
K864505 · Spacelabs, Inc. · Nov 1986
MODEL 6000 AMBULATORY ECG ANALYSIS SYSTEM
K863724 · Oxford Medilog, Inc. · Nov 1986
Q4000 AND Q3040 ELECTROCARDIOGRAPH MONITOR
K863159 · Quinton, Inc. · Oct 1986
PC ARRHYTHMIA DETECTION/ANALYSIS - ARRHYTHMIA III
K860980 · Spacelabs, Inc. · May 1986