Cleared Traditional

K043015 - 3L SURGICAL DRAPES

K043015 is an FDA 510(k) clearance for 3L SURGICAL DRAPES, manufactured by 3l Medical Products Co., Ltd.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 286-day FDA review.

K043015 · 3l Medical Products Co., Ltd. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2005
Decision
286d
Days
Class 2
Risk

K043015 is an FDA 510(k) clearance for the 3L SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by 3l Medical Products Co., Ltd. (Los Angeles, US). The FDA issued a Cleared decision on August 15, 2005 after a review of 286 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.

View all 3l Medical Products Co., Ltd. devices

FDA 510(k) Submission Details - K043015

510(k) Number K043015 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 02, 2004
Decision Date August 15, 2005
Days to Decision 286 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
157d slower than avg
Panel avg: 129d · This submission: 286d
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 242
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K043015.
EQUIPMENT SLUSH DRAPE
K053495 · Advance Medical Designs, Inc. · Mar 2006
GORE-TEX NON-STERILE SURGICAL GOWNS
K052833 · Medline Industries, Inc. · Feb 2006
STERILE EQUIPMENT COVERS
K052395 · Volcano Corporation · Dec 2005
MICROTEK EQUIPMENT DRAPES
K050322 · Microtek Medical, Inc. · May 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
ALEXIS WOUND RETRACTOR
K031889 · Applied Medical Resources Corp. · Sep 2003