# K012957: Towel Drape, Models 4409, 4410

- Pathway: 510(k) (Traditional)
- Applicant: Dynarex Corp.
- Decided: Mar 6, 2002 after 183 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 K911039 (1991). 2 ancestors in all.
No later device cites it as a predicate yet.
0 of 3 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K980210: Various Surgical or Patient Drapes, Gel-Lite, LLC (1998) Summary page 1.
- K911039: Invotec Ear Drape, Invotec International, Inc. (1991) Summary page 1.
- (no number) 18" x 26" Towel Drape, manufactured for Dynarex Corporation: named in the summary without a submission number

## Indications for use
The Dynarex Towel Drape is a device consisting of natural or synthetic materials intended to be used as a patient covering during General Surgical Procedures.

Source page: https://510kreport.com/device/K012957
Methodology: https://510kreport.com/methodology