Cleared Traditional

K141324 - HONGYU DISPOSABLE SURGICAL DRAPES (FDA 510(k) Clearance)

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

K141324 · Weihai Hongyu Nonwoven Fabric Products Co., Ltd. · General Hospital
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Apr 2015
Decision
329d
Days
Class 2
Risk

K141324 is an FDA 510(k) clearance for the HONGYU DISPOSABLE SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Weihai Hongyu Nonwoven Fabric Products Co., Ltd. (Shanghai, CN). The FDA issued a Cleared decision on April 14, 2015 after a review of 329 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 Weihai Hongyu Nonwoven Fabric Products Co., Ltd. devices

Submission Details

510(k) Number K141324 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 20, 2014
Decision Date April 14, 2015
Days to Decision 329 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
201d slower than avg
Panel avg: 128d · This submission: 329d
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.