Cleared Traditional

K230645 - BeneHold™ Surgical Incise Drape with CHG antimicrobial II (FDA 510(k) Clearance)

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

K230645 · Avery Dennison Medical , Ltd. · General Hospital
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Oct 2023
Decision
231d
Days
Class 2
Risk

K230645 is an FDA 510(k) clearance for the BeneHold™ Surgical Incise Drape with CHG antimicrobial II. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Avery Dennison Medical , Ltd. (Longford, IE). The FDA issued a Cleared decision on October 25, 2023 after a review of 231 days - an extended review cycle.

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. Standard predicate reliance. 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.

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Submission Details

510(k) Number K230645 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received March 08, 2023
Decision Date October 25, 2023
Days to Decision 231 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
PCCP Authorized No
Regulatory Context
Review time vs. panel average
103d slower than avg
Panel avg: 128d · This submission: 231d
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.