Cleared Traditional

K202208 - BeneHold Surgical Incise Drape with CHG antimicrobial (FDA 510(k) Clearance)

Class II General Hospital device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

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

Submission Details

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
230d slower than avg
Panel avg: 128d · This submission: 358d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

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.