Cleared Traditional

K960849 - MAGNO ALARM

K960849 is an FDA 510(k) clearance for MAGNO ALARM, manufactured by Cardiac Assist Devices, Inc.. The device is a Class 1 Cardiovascular device with product code DTG cleared through the Traditional 510(k) pathway after a 400-day FDA review.

K960849 · Cardiac Assist Devices, Inc. · Cardiovascular device
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Mar 1997
Decision
400d
Days
Class 1
Risk

K960849 is an FDA 510(k) clearance for the MAGNO ALARM. Classified as Magnet, Test, Pacemaker (product code DTG), Class I - General Controls.

Submitted by Cardiac Assist Devices, Inc. (Cleveland, US). The FDA issued a Cleared decision on March 26, 1997 after a review of 400 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the Cardiovascular FDA review panel, regulated under 21 CFR 870.3690 - 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. Elevated predicate reliance profile. 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 Cardiac Assist Devices, Inc. devices

FDA 510(k) Submission Details - K960849

510(k) Number K960849 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 20, 1996
Decision Date March 26, 1997
Days to Decision 400 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 125d · This submission: 400d
Pathway characteristics
Predicate-based equivalence.

DTG Device Classification - Class 1, General Controls

Product Code DTG Magnet, Test, Pacemaker
Device Class Class 1 - General Controls
CFR Regulation 21 CFR 870.3690
What this classification means

Class I devices are subject to general controls only and most are exempt from 510(k) premarket notification. They represent the lowest regulatory burden in the FDA device framework.