# K051625: Barrier Surgical Drapes

- Pathway: 510(k) (Special)
- Applicant: Molnlycke Health Care, Inc.
- Decided: Jul 14, 2005 after 24 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 K760807 (1976). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K760807: Barrier General Surgery Pack, Surgikos, Inc. (1976) Summary page 1.
- K760902: Barrier Under Buttocks Drape, Surgikos, Inc. (1976) Summary page 1.
- K760933: Barrier Universal Sheet, Surgikos, Inc. (1976) Summary page 1.
- K760937: Barrier Neuro Sheet, Surgikos, Inc. (1976) Summary page 1.
- K780282: Barrier Hip Pack W/ Fabric 450, Surgikos, Inc. (1978) Summary page 1.
- K780839: Barrier Pediatric/Incise Drape 450, Surgikos, Inc. (1978) Summary page 1.
- K780840: Barrier Laparotomy Sheet 450, Surgikos, Inc. (1978) Summary page 1.
- K780841: Barrier Medium Sheet 450, Surgikos, Inc. (1978) Summary page 1.
- K780842: Barrier Basic Pack Fabric 450, Surgikos, Inc. (1978) Summary page 1.
- K780843: Barrier Abdominal Pack Fabric 450, Surgikos, Inc. (1978) Summary page 1.
- K780844: Barrier Obstetrical Pack Fabric 450, Surgikos, Inc. (1978) Summary page 1.
- K780856: Barrier Gynecology Pack Fabric 450, Surgikos, Inc. (1978) Summary page 1.

## Indications for use
BARRIER® surgical drapes are intended for single use to be used as a protective patient covering, such as to isolate a site on a surgical incision from microbial and other contamination.

Source page: https://510kreport.com/device/K051625
Methodology: https://510kreport.com/methodology