Cleared Traditional

K140369 - MEDLINE NEURO SPONGE (FDA 510(k) Clearance)

Class II Neurology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K140369 · Medline Industries, Inc. · Neurology device
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Sep 2014
Decision
224d
Days
Class 2
Risk

K140369 is an FDA 510(k) clearance for the MEDLINE NEURO SPONGE. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by Medline Industries, Inc. (Mundelein, US). The FDA issued a Cleared decision on September 26, 2014 after a review of 224 days - an extended review cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.4700 - 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 Medline Industries, Inc. devices

Submission Details

510(k) Number K140369 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 14, 2014
Decision Date September 26, 2014
Days to Decision 224 days
Submission Type Traditional
Review Panel Neurology (NE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
76d slower than avg
Panel avg: 148d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code HBA Neurosurgical Paddie
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.4700
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.