Cleared Traditional

K041244 - POLYGRAM NET BIOFEEDBACK APPLICATION

K041244 is the FDA 510(k) clearance for POLYGRAM NET BIOFEEDBACK APPLICATION by Medtronic Vascular. It is a Class 2 Neurology device (product code HCC) cleared through the Traditional 510(k) pathway after a 93-day FDA review.

K041244 · Medtronic Vascular · Neurology device
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Aug 2004
Decision
93d
Days
Class 2
Risk

K041244 is an FDA 510(k) clearance for the POLYGRAM NET BIOFEEDBACK APPLICATION. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Medtronic Vascular (Shoreview, US). The FDA issued a Cleared decision on August 12, 2004 after a review of 93 days - within the typical 510(k) review window.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.5050 - the FDA neurology device 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 Neurology review framework, consistent with the majority of Class II 510(k) submissions.

View all Medtronic Vascular devices

Submission Details

510(k) Number K041244 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 11, 2004
Decision Date August 12, 2004
Days to Decision 93 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
55d faster than avg
Panel avg: 148d · This submission: 93d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HCC Device, Biofeedback
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.5050
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 Neurology devices follow this clearance model.

Regulatory Peers - HCC Device, Biofeedback

All 7
Devices cleared under the same product code (HCC) and FDA review panel - the closest regulatory comparables to K041244.
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K972487 · Chattanooga Group, Inc. · Sep 1997