# K080796: Sri LP Drape

- Pathway: 510(k) (Abbreviated)
- Applicant: Sri/Surgical Express
- Decided: Nov 17, 2008 after 242 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SRISurgical Express SRI LP Drapes are reusable drapes, including back table covers (model numbers 1616,1822, 3010, 3015, 3020, 3025, 3030, and 6113), mayo stand covers (model numbers 1247C, 3000, 30004, 3006, and 6247A), and drape sheets (model numbers 3870, 3871, 3872, and 3873) that are intended to be used by health care personnel during surgical procedures to protect both the surgical patient and the operating room personnel from transfer of microorganisms, body fluids, and particulate material.

Source page: https://510kreport.com/device/K080796
Methodology: https://510kreport.com/methodology