Cleared Traditional

K091854 - BIS CLICK SENSOR/CABLE

K091854 is an FDA 510(k) clearance for BIS CLICK SENSOR/CABLE, manufactured by Aspect Medical Systems, Inc.. The device is a Class 2 Neurology device with product code GXY cleared through the Traditional 510(k) pathway after a 13-day FDA review.

K091854 · Aspect Medical Systems, Inc. · Neurology device
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Jul 2009
Decision
13d
Days
Class 2
Risk

K091854 is an FDA 510(k) clearance for the BIS CLICK SENSOR/CABLE. Classified as Electrode, Cutaneous (product code GXY), Class II - Special Controls.

Submitted by Aspect Medical Systems, Inc. (Norwood, US). The FDA issued a Cleared decision on July 2, 2009 after a review of 13 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. 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 Aspect Medical Systems, Inc. devices

FDA 510(k) Submission Details - K091854

510(k) Number K091854 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received June 19, 2009
Decision Date July 02, 2009
Days to Decision 13 days
Submission Type Traditional
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
135d faster than avg
Panel avg: 148d · This submission: 13d
Pathway characteristics
Predicate-based equivalence. No clinical trials required. 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

Underwriters Laboratories, Inc.
CASEY CONRY

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 K091854.
MODIFICATION TO:KNEEHAB XP CONDUCTIVE GARMENT, MODEL 411
K092793 · Bio-Medical Research, Ltd. · Dec 2009
BIS QUATRO SENSOR
K093183 · Aspect Medical Systems, Inc. · Oct 2009
LIFECARE ELECTRODES
K083302 · Everyway Medical Instruments Co.,Ltd · Aug 2009
GE ENTROPY SENSOR
K082540 · Ge Healthcare · Nov 2008
GE ENTROPY SENSOR (REFM1038681) AND GE ENTROPY CABLE (REF M1050784)
K062580 · Ge Healthcare · Dec 2007
ZIPPREP ELECTRODE
K070069 · Aspect Medical Systems, Inc. · Feb 2007