Cleared Special

K041670 - BIS PEDIATRIC SENSOR

K041670 is an FDA 510(k) clearance for BIS PEDIATRIC SENSOR, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Special 510(k) pathway after a 15-day FDA review.

K041670 · Aspect Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2004
Decision
15d
Days
Class 2
Risk

K041670 is an FDA 510(k) clearance for the BIS PEDIATRIC SENSOR. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Newton, US). The FDA issued a Cleared decision on July 6, 2004 after a review of 15 days - a notably fast clearance cycle.

This device falls under the Neurology FDA review panel, regulated under 21 CFR 882.1320 - the FDA neurology device framework. As a Special 510(k), this submission covers a manufacturer modification to an existing cleared device rather than a new device introduction.

Device pattern: Iterative device modification. Low regulatory complexity profile. This Special 510(k) clearance confirms that the manufacturer's modifications remained within the established regulatory envelope of the original cleared device.

View all Aspect Medical Systems, Inc. devices

FDA 510(k) Submission Details - K041670

510(k) Number K041670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 21, 2004
Decision Date July 06, 2004
Days to Decision 15 days
Submission Type Special
Review Panel Neurology (NE)
Summary Summary PDF
Third-party Review Yes - reviewed by an FDA-accredited third party
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
133d faster than avg
Panel avg: 148d · This submission: 15d
Pathway characteristics
Modification to existing cleared device. Third-party reviewed.

GXY Device Classification - Class 2, Special Controls

Product Code GXY Electrode, Cutaneous
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 882.1320
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 Consultant

Entela, Inc.
N.E. DEVINE, JR.

The regulatory consultant manages the 510(k) submission process on behalf of the applicant - coordinating technical documentation, predicate strategy and FDA communications. Identifying the consultant behind a submission is a key signal for competitive regulatory intelligence.

Regulatory Peers - GXY Electrode, Cutaneous

All 184
Devices cleared under the same product code (GXY) and FDA review panel - the closest regulatory comparables to K041670.
XLTEK CLEAN SIGNAL ADHESIVE ELECTRODES
K061269 · Excel Tech. , Ltd. · Aug 2006
AMBU NEUROLINE GROUND
K051529 · Ambu, Inc. · Aug 2005
VERSASTIM, PERFOAMAX, SURGI-STIM, FASTSTART
K041953 · Conmedcorp · Aug 2004
AMBU NEUROLINE SINGLE PATIENT EEG/EP CUP ELECTRODE
K032278 · Ambu, Inc. · Mar 2004
LIFECARE 5*5 CM SQUARE, LIFECARE 4*4 CM SQUARE, LIFECARE 5 CM ROUND, LIFECARE 7.5 CM ROUND, LIFECARE 4*6 CM OVAL
K012463 · Everyway Medical Instruments Co.,Ltd · Feb 2002
MODIFICATION TO:APEX MEDICAL IF-4100
K013813 · Apex Medical Corp. · Dec 2001