# K041080: Surgical Drape Kit - D.I.R.R.a. SRL

- Pathway: 510(k) (Traditional)
- Applicant: D.I.R.R.a. S.R.L.
- Decided: Nov 30, 2004 after 218 days
- Product code: LRO (General Surgery Tray)
- 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 K934688 (1994). 1 ancestor in all.
1 later device descends from it; 1 cites it directly.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K934688: Sterile Design, Sterile Design, Inc. (1994) Summary page 1.

## Most influential descendants
- K110724: Surgical Procedure Packs (2011), 0 descendants of its own

## Indications for use
The D.I.R.R.A. surgical drape device kit is composed of natural or synthetic materials and intended to be used as a protective patient covering, such as isolate a site of surgical incision from microbial or other contamination.

Source page: https://510kreport.com/device/K041080
Methodology: https://510kreport.com/methodology