Cleared Traditional

K081476 - SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE

K081476 is an FDA 510(k) clearance for SURGICAL CONCEPT DESIGNS POSITIONOR SUR..., manufactured by Surgical Concept Designs. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 73-day FDA review.

K081476 · Surgical Concept Designs · General Hospital
Download Printable Device Report (PDF)
Optimized for regulatory review, auditing and printing
Aug 2008
Decision
73d
Days
Class 2
Risk

K081476 is an FDA 510(k) clearance for the SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Surgical Concept Designs (Hackensack, US). The FDA issued a Cleared decision on August 8, 2008 after a review of 73 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 Surgical Concept Designs devices

FDA 510(k) Submission Details - K081476

510(k) Number K081476 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received May 27, 2008
Decision Date August 08, 2008
Days to Decision 73 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
56d faster than avg
Panel avg: 129d · This submission: 73d
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 232
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K081476.
BUSSE SURGICAL DRAPES III
K092212 · Busse Hospital Disposables, Inc. · Oct 2009
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