# K131571: Avd Right Radial Drape

- Pathway: 510(k) (Traditional)
- Applicant: Advanced Vascular Dynamics
- Decided: Jan 31, 2014 after 246 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
Longest line of descent: 1 generation back to K050508 (2005). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050508: Hvo, Inc., Disposable Non-Sterile Surgical Drapes, Haywood Vocational Opportunities (2005) Summary page 1.

## Indications for use
The AVID Left and Right Radial Drapes are single use sterile devices intended for use by medical professionals as a protective patient covering, such as to isolate a site of surgical incision or vascular puncture from microbial and other contamination. The drapes are attached to the patient in proximity to a vascular puncture site to isolate vascular access punctures from microbial and other contamination during procedures including angiographies and percutaneous interventions.

Source page: https://510kreport.com/device/K131571
Methodology: https://510kreport.com/methodology