# K071491: Arrow International, Inc., Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Arrow Intl., Inc.
- Decided: Oct 10, 2007 after 133 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 K850960 (1986). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K032666: Medline Sterile Disposable Surgical Gowns/Drapes, Medline Industries, Inc. (2005) Summary page 1.
- K850960: Non-Absorbent Drapes & Absorbent Towels, Excel Health Care Products (1986) Summary page 1.

## Indications for use
Arrow Surgical Drapes are intended to be used as a protective patient covering to isolate a site of surgical incision from microbial and other contamination

Source page: https://510kreport.com/device/K071491
Methodology: https://510kreport.com/methodology