Cleared Traditional

K140369 - MEDLINE NEURO SPONGE

K140369 is an FDA 510(k) clearance for MEDLINE NEURO SPONGE, manufactured by Medline Industries, Inc.. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 224-day FDA review.

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.

FDA 510(k) Submission Details - K140369

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
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
75d slower than avg
Panel avg: 149d · This submission: 224d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

HBA Device Classification - Class 2, Special Controls

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.

Regulatory Peers - HBA Neurosurgical Paddie

All 17
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K140369.
Codman Surgical Patties & Strips
K193346 · Integra LifeSciences Corporation · Nov 2020
AMERICAN SURGICAL COMPANY/ NEUROSURGICAL SPONGES (BRAND)
K112598 · American Surgical Company, LLC · Jun 2013
DELICOT
K121822 · American Surgical Company, LLC · Sep 2012
NEUROSURGICAL SPONGES AND PADDLES AND NEURO PATTIES AND NEUROSPONGES
K073576 · Harod Enterprises, Inc. · Feb 2008
AESCULAP NEURO PATTIES
K062406 · Aesculap, Inc. · Sep 2006
AESCULAP NEURO PATTIES, NEUROSORB 4, 6, AND 75 (GREEN & WHITE)
K031008 · Aesculap · May 2003
K140369 · MEDLINE NEURO SPONGE
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