# K020581: Coloshield Colonoscopy Drape Model E2000

- Pathway: 510(k) (Traditional)
- Applicant: Medical Concepts Development, Inc.
- Decided: Sep 18, 2002 after 209 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.
2 later devices descend 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)
- None. The FDA summary names its predicate without a number.
- (no number) 3M Steri-Drape 1100: named in the summary without a submission number

## Most influential descendants
- K070406: Endodrape (2007), 1 descendant of its own
- K080341: Endodrape (TM) (2008), 0 descendants of its own

## Indications for use
Use the ColoSHIELD during colonoscopy procedures to protect the clinical staff from patient secretions and to help maintain a cleaner procedural site.

Source page: https://510kreport.com/device/K020581
Methodology: https://510kreport.com/methodology