# K070432: General Surgery Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Welmed, Inc.
- Decided: Sep 24, 2007 after 223 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: 3 generations back to K030365 (2003). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K052169: Imc Surgical Drapes, International Medsurg Connection, Inc. (2005) Summary page 2.

## Indications for use
Disposable sterile drapes are used in the operating room as a protective covering, for both patient and operating room staff, from the transfer of body fluids, micro-organisms and particulates. Drapes provided as sterile and non-sterile. Non-sterile surgical drapes are to be sold to OEMs for EtO sterilization according to ISO 11135. Sterile Surgical Drapes are to be sold directly to users after EtO sterilization validation to ISO 11135.

Source page: https://510kreport.com/device/K070432
Methodology: https://510kreport.com/methodology