# K980210: Various Surgical or Patient Drapes

- Pathway: 510(k) (Traditional)
- Applicant: Gel-Lite, LLC
- Decided: May 15, 1998 after 114 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 K911039 (1991). 1 ancestor in all.
1 later device descends 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)
- K911039: Invotec Ear Drape, Invotec International, Inc. (1991) Summary page 1.

## Most influential descendants
- K012957: Towel Drape, Models 4409, 4410 (2002), 0 descendants of its own

## Indications for use
The various surgical or patient drapes manufactured by DEKA Medical, Inc., consist of natural or synthetic materials intended to be used as a protective patient covering during surgical procedures. The primary purpose of the drapes is to isolate a site of surgical incision from microbial or other contamination.

Source page: https://510kreport.com/device/K980210
Methodology: https://510kreport.com/methodology