# K050508: Hvo, Inc., Disposable Non-Sterile Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Haywood Vocational Opportunities
- Decided: Apr 27, 2005 after 58 days
- Product code: KKX (Drape, Surgical, Antimicrobial)
- Device class: 2
- Regulation: 21 CFR 878.4370
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
3 later devices descend from it; 2 cite it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names no predicate by number.

## Most influential descendants
- K070406: Endodrape (2007), 1 descendant of its own
- K131571: Avd Right Radial Drape (2014), 0 descendants of its own
- K080341: Endodrape (TM) (2008), 0 descendants of its own

## Indications for use
HVO surgical drapes are made from natural and synthetic materials intended to be used by medical professionals as protective coverings, such as a patient covering to isolate a site for surgical incision from contamination. They are designed to be repackaged and/or sterilized before use. This single use product is a disposable non-sterile drape designed to be re-packaged and/or sterilized prior to use. This product may be sterilized using Ethylene Oxide (EO) following the Validation and Routine Control under ANSI/AMMI/ISO 11135. For more information about sterilization of this product, contact HVO, Inc.

Source page: https://510kreport.com/device/K050508
Methodology: https://510kreport.com/methodology