Cleared Traditional

MAGNO ALARM (K960849) - FDA 510(k) Clearance

Class I Cardiovascular device.

K960849 · Cardiac Assist Devices, Inc. · Cardiovascular device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
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

Submission Details

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
Regulatory Context
Review time vs. panel average
275d slower than avg
Panel avg: 125d · This submission: 400d
Pathway characteristics
Predicate-based equivalence.

Device Classification

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.