Cleared Traditional

K003670 - PATIENT DRAPE

K003670 is the FDA 510(k) clearance for PATIENT DRAPE by Advance Medical Designs, Inc.. It is a Class 2 General Hospital device (product code KKX) cleared through the Traditional 510(k) pathway after a 59-day FDA review.

K003670 · Advance Medical Designs, Inc. · General Hospital
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Jan 2001
Decision
59d
Days
Class 2
Risk

K003670 is an FDA 510(k) clearance for the PATIENT DRAPE, SURGICAL. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Advance Medical Designs, Inc. (Marietta, US). The FDA issued a Cleared decision on January 26, 2001 after a review of 59 days - a notably fast clearance 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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Advance Medical Designs, Inc. devices

Submission Details

510(k) Number K003670 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 28, 2000
Decision Date January 26, 2001
Days to Decision 59 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
70d faster than avg
Panel avg: 129d · This submission: 59d
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.

Regulatory Peers - KKX Drape, Surgical

All 146
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K003670.
DRAPES WITH ABSORBENT REINFORCEMENT
K023425 · Allegiance Healthcare Corp. · Nov 2002
MEDLINE ASEP PLUS SURGICAL DRAPES
K023432 · Medline Industries, Inc. · Nov 2002
WOUND PROTECTOR/RETRACTOR
K020435 · Applied Medical Resources Corp. · Apr 2002
EQUIPMENT DRAPES
K002508 · Allegiance Healthcare Corp. · Sep 2000
RESOLVE SURGICAL O.R. TOWELS
K001667 · Allegiance Healthcare Corp. · Jun 2000
CONVERTORS EQUIPMENT DRAPES
K000417 · Allegiance Healthcare Corp. · Mar 2000