Cleared Abbreviated

K102666 - KIMBERLY-CLARK SURGICAL DRAPES WITH AAM...

K102666 is an FDA 510(k) clearance for KIMBERLY-CLARK SURGICAL DRAPES WITH AAM..., manufactured by Kimberly-Clark Corp.. The device is a Class 2 General Hospital device with product code KKX cleared through the Abbreviated 510(k) pathway after a 55-day FDA review.

K102666 · Kimberly-Clark Corp. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Nov 2010
Decision
55d
Days
Class 2
Risk

K102666 is an FDA 510(k) clearance for the KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Kimberly-Clark Corp. (Roswell, US). The FDA issued a Cleared decision on November 9, 2010 after a review of 55 days - a notably fast clearance cycle.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital device framework. The Abbreviated 510(k) pathway was used, relying on FDA-recognized standards to demonstrate substantial equivalence.

Device pattern: Standards-based predicate clearance. Standards-verified equivalence. The Abbreviated pathway signals strong alignment with FDA-recognized performance standards - typically associated with lower review burden and faster clearance cycles.

View all Kimberly-Clark Corp. devices

FDA 510(k) Submission Details - K102666

510(k) Number K102666 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received September 15, 2010
Decision Date November 09, 2010
Days to Decision 55 days
Submission Type Abbreviated
Review Panel General Hospital (HO)
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
74d faster than avg
Panel avg: 129d · This submission: 55d
Pathway characteristics
Standards-based clearance path. Third-party reviewed.

KKX Device Classification - Class 2, Special Controls

Product Code KKX Drape, Surgical
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 878.4370
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 General Hospital devices follow this clearance model.

Regulatory Consultant

Underwriters Laboratories, Inc.
NED DEVINE

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 - KKX Drape, Surgical

All 174
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K102666.
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
SURGISLEEVE WOUND PROTECTOR
K140064 · Covidien · Mar 2014
TIBURON SURGICAL DRAPE
K130404 · Cardinal Health200, LLC · Jul 2013
BUSSE SURGICAL DRAPES IV
K093909 · Busse Hospital Disposables, Inc. · May 2010
BUSSE SURGICAL DRAPES III
K092212 · Busse Hospital Disposables, Inc. · Oct 2009
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp. · Mar 2009

FDA 510(k) Resources - General Hospital

Additional regulatory intelligence related to this FDA 510(k) submission, including predicate strategy, review pathways and device classification guidance.