Cleared Traditional

K202208 - BeneHold Surgical Incise Drape with CHG...

K202208 is an FDA 510(k) clearance for BeneHold Surgical Incise Drape with CHG..., manufactured by Avery Dennison Belgie Bvba. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 358-day FDA review.

K202208 · Avery Dennison Belgie Bvba · General Hospital
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Jul 2021
Decision
358d
Days
Class 2
Risk

K202208 is an FDA 510(k) clearance for the BeneHold Surgical Incise Drape with CHG antimicrobial. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Avery Dennison Belgie Bvba (Turnhout, BE). The FDA issued a Cleared decision on July 30, 2021 after a review of 358 days - an unusually long review period, suggesting complex equivalence evaluation.

This device falls under the General Hospital FDA review panel, regulated under 21 CFR 878.4370 - the FDA general hospital 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. Elevated predicate reliance profile. This clearance follows a standard predicate-based equivalence path within the General Hospital review framework, consistent with the majority of Class II 510(k) submissions.

View all Avery Dennison Belgie Bvba devices

FDA 510(k) Submission Details - K202208

510(k) Number K202208 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received August 06, 2020
Decision Date July 30, 2021
Days to Decision 358 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
229d slower than avg
Panel avg: 129d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

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 Peers - KKX Drape, Surgical

All 174
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K202208.
BeneHold™ Surgical Incise Drape with CHG antimicrobial II
K230645 · Avery Dennison Medical , Ltd. · Oct 2023
3M™ Ioban™ CHG Chlorhexidine Gluconate Incise Drape (contains 2% w/w CHG)
K222578 · 3M Company · May 2023
ControlRad Sterile Cover
K200238 · Controlrad, Inc. · Apr 2020
SURGISLEEVE WOUND PROTECTOR
K140064 · Covidien · Mar 2014
TIBURON SURGICAL DRAPE
K130404 · Cardinal Health200, LLC · Jul 2013
KIMBERLY-CLARK SURGICAL DRAPES WITH AAMI LIQUID BARRIER LEVEL 4 CLAIM
K102666 · Kimberly-Clark Corp. · Nov 2010