Cleared Traditional

K914600 - NEUROLOGICAL SPONGE

K914600 is an FDA 510(k) clearance for NEUROLOGICAL SPONGE, manufactured by I M, Inc.. The device is a Class 2 Neurology device with product code HBA cleared through the Traditional 510(k) pathway after a 446-day FDA review.

K914600 · I M, Inc. · Neurology device
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Dec 1992
Decision
446d
Days
Class 2
Risk

K914600 is an FDA 510(k) clearance for the NEUROLOGICAL SPONGE. Classified as Neurosurgical Paddie (product code HBA), Class II - Special Controls.

Submitted by I M, Inc. (Fairfield, US). The FDA issued a Cleared decision on December 30, 1992 after a review of 446 days - an unusually long review period, suggesting complex equivalence evaluation.

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: High-complexity regulatory submission. Elevated predicate reliance profile. The extended review timeline suggests the FDA required additional documentation before confirming substantial equivalence - a pattern common in complex or first-of-kind Neurology submissions.

View all I M, Inc. devices

FDA 510(k) Submission Details - K914600

510(k) Number K914600 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received October 11, 1991
Decision Date December 30, 1992
Days to Decision 446 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
298d slower than avg
Panel avg: 148d · This submission: 446d
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 11
Devices cleared under the same product code (HBA) and FDA review panel - the closest regulatory comparables to K914600.
AMERICAN SURGICAL SPONGES/NEUROSURGICAL SPONGES
K962807 · American Surgical Sponges · May 1997
ULTRACELL NEURO SPONGES
K970328 · Ultracell Medical Technologies, Inc. · Apr 1997
ULTRACELL NEURO SPONGES
K950647 · Ultracell Medical Technologies, Inc. · Aug 1995
CODMAN SURGICAL PATTIE
K880402 · Codman & Shurtleff, Inc. · Mar 1988