Cleared Traditional

K012384 - EAR MUFFINS

K012384 is an FDA 510(k) clearance for EAR MUFFINS, manufactured by Bio-Logic Systems Corp.. The device is a Class 2 Neurology device with product code HCC cleared through the Traditional 510(k) pathway after a 80-day FDA review.

K012384 · Bio-Logic Systems Corp. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Oct 2001
Decision
80d
Days
Class 2
Risk

K012384 is an FDA 510(k) clearance for the EAR MUFFINS. Classified as Device, Biofeedback (product code HCC), Class II - Special Controls.

Submitted by Bio-Logic Systems Corp. (Mudelein, US). The FDA issued a Cleared decision on October 15, 2001 after a review of 80 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Bio-Logic Systems Corp. devices

FDA 510(k) Submission Details - K012384

510(k) Number K012384 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 2001
Decision Date October 15, 2001
Days to Decision 80 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
68d faster than avg
Panel avg: 148d · This submission: 80d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HCC Device Classification - Class 2, Special Controls

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 K012384.
Freespira
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K945826 · Medical Device Inspection Co., Inc. · Aug 1995