Cleared Traditional

K050508 - HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES

K050508 is an FDA 510(k) clearance for HVO, manufactured by Haywood Vocational Opportunities. The device is a Class 2 General Hospital device with product code KKX cleared through the Traditional 510(k) pathway after a 58-day FDA review.

K050508 · Haywood Vocational Opportunities · General Hospital
Download Printable Device Report (PDF) Official FDA 510(k) Summary (PDF)
Optimized for regulatory review, auditing and printing
Apr 2005
Decision
58d
Days
Class 2
Risk

K050508 is an FDA 510(k) clearance for the HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES. Classified as Drape, Surgical (product code KKX), Class II - Special Controls.

Submitted by Haywood Vocational Opportunities (Waynesville, US). The FDA issued a Cleared decision on April 27, 2005 after a review of 58 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.

FDA 510(k) Submission Details - K050508

510(k) Number K050508 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received February 28, 2005
Decision Date April 27, 2005
Days to Decision 58 days
Submission Type Traditional
Review Panel General Hospital (HO)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
71d faster than avg
Panel avg: 129d · This submission: 58d
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 420
Devices cleared under the same product code (KKX) and FDA review panel - the closest regulatory comparables to K050508.
IMC DRAPES
K050538 · Intl. Medsurg Connection, Inc. · Jun 2005
MICROTEK EQUIPMENT DRAPES
K050322 · Microtek Medical, Inc. · May 2005
LASIK EYE DRAPE
K042977 · Odyssey Medical, Inc. · May 2005
DRAPE, SURGICAL, X-RAY ELEMENT, MODELS NON STERILE 6120-00, STERILE 704-B, NON STERILE 6124-00X, STERILE 704-BX
K042526 · Medical Action Industries, Inc. · Apr 2005
MEDLINE STERILE DISPOSABLE SURGICAL GOWNS/DRAPES
K032666 · Medline Industries, Inc. · Mar 2005
UNDER BUTTOCKS DRAPE
K042893 · International Medsurg Connection, Inc. · Mar 2005
K050508 · HVO, INC., DISPOSABLE NON-STERILE SURGICAL DRAPES
Download PDF FDA Summary Haywood Vocational Op…