Cleared Traditional

K092364 - MODEL 220 PATIENT MAGNET

K092364 is an FDA 510(k) clearance for MODEL 220 PATIENT MAGNET, manufactured by Cyberonics, Inc.. The device is a Class 1 Cardiovascular device with product code DTG cleared through the Traditional 510(k) pathway after a 90-day FDA review.

K092364 · Cyberonics, Inc. · Cardiovascular device
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Nov 2009
Decision
90d
Days
Class 1
Risk

K092364 is an FDA 510(k) clearance for the MODEL 220 PATIENT MAGNET. Classified as Magnet, Test, Pacemaker (product code DTG), Class I - General Controls.

Submitted by Cyberonics, Inc. (Houston, US). The FDA issued a Cleared decision on November 3, 2009 after a review of 90 days - within the typical 510(k) review window.

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. 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 Cyberonics, Inc. devices

FDA 510(k) Submission Details - K092364

510(k) Number K092364 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 05, 2009
Decision Date November 03, 2009
Days to Decision 90 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
35d faster than avg
Panel avg: 125d · This submission: 90d
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.