Cleared Traditional

K070432 - GENERAL SURGERY DRAPES

K070432 is an FDA 510(k) clearance for GENERAL SURGERY DRAPES, manufactured by Welmed, Inc.. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 223-day FDA review.

K070432 · Welmed, Inc. · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Sep 2007
Decision
223d
Days
Class 2
Risk

K070432 is an FDA 510(k) clearance for the GENERAL SURGERY DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Welmed, Inc. (San Diego, US). The FDA issued a Cleared decision on September 24, 2007 after a review of 223 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 Welmed, Inc. devices

FDA 510(k) Submission Details - K070432

510(k) Number K070432 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 13, 2007
Decision Date September 24, 2007
Days to Decision 223 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
94d slower than avg
Panel avg: 129d · This submission: 223d
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 233
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K070432.
KIMBERLY-CLARK KC100 SURGICAL DRAPES, MODEL KC 100, KIMBERLY-CLARK KC100 SURGICAL EQUIPMENT COVERS, MODEL KC 100
K083234 · Kimberly-Clark Corp. · Mar 2009
BUSSE SURGICAL DRAPE
K082297 · Busse Hospital Disposables, Inc. · Dec 2008
ARROW INTERNATIONAL, INC., SURGICAL DRAPES
K071491 · Arrow Intl., Inc. · Oct 2007
TIBURON DRAPE, MODEL 9349N/ OPTIMA DRAPE, MODEL 9446N
K061762 · Cardinal Health, Inc. · Aug 2006
MICROTEK MEDICAL WARMING DRAPE
K060200 · Microtek Medical, Inc. · May 2006
EQUIPMENT SLUSH DRAPE
K053495 · Advance Medical Designs, Inc. · Mar 2006