# K031287: Steri-Drape Surgical Drapes

- Pathway: 510(k) (Traditional)
- Applicant: 3M Company
- Decided: Sep 10, 2003 after 140 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.
10 later devices descend from it; 7 cite it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Steri-Drape Fabric Surgical Drapes: named in the summary without a submission number

## Most influential descendants
- K130404: Tiburon Surgical Drape (2013), 1 descendant of its own
- K083424: Busse Surgical Drape (2009), 1 descendant of its own
- K082297: Busse Surgical Drape (2008), 1 descendant of its own
- K141324: Hongyu Disposable Surgical Drapes (2015), 0 descendants of its own
- K140195: Surgical Drape (2014), 0 descendants of its own

## Indications for use
3M Steri-DrapeTM Surgical Fabric Drapes are used to create a sterile field for a surgical procedure. They are provided sterile using ethylene oxide or gamma irradiation, and intended for external use only. 3M Steri-DrapeTM non-sterile fabric drapes are provided to other manufacturers for further processing using ethylene oxide. 3M provides information on compatibility with ethylene oxide processing.

Source page: https://510kreport.com/device/K031287
Methodology: https://510kreport.com/methodology