# K081476: Surgical Concept Designs Positionor Surgical Drape

- Pathway: 510(k) (Traditional)
- Applicant: Surgical Concept Designs
- Decided: Aug 8, 2008 after 73 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: 2 generations back to K931417 (1995). 3 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 5 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K050322: Microtek Equipment Drapes, Microtek Medical, Inc. (2005) Summary page 1.

## Cited in the summary but kept off the family tree
- K053594: Advance Medical Designs Slush Drapes. Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1.

## Most influential descendants
- K091343: Mri Neuro Drape (2009), 0 descendants of its own

## Indications for use
The Surgical Concept Designs Surgical Drape, Model #01 001 is used to cover medical equipment in a surgical setting. It is to be used in general surgery.

Source page: https://510kreport.com/device/K081476
Methodology: https://510kreport.com/methodology