# K252823: Dukal Crepe Paper Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Dukal, LLC
- Decided: May 28, 2026 after 266 days
- Product code: FRG (Wrap, Sterilization)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K931202 (1993). 3 ancestors in all.
No later device cites it as a predicate yet.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K200335: Sterisheet Sterilization Wrap, Andersen Sterilizers, Inc. (2020) Summary page 6.

## Indications for use
The Dukal Crepe Paper sterilization wraps are intended to be used to enclose another medical device that is to be sterilized by a healthcare provider using: • In 100% ethylene oxide (EO) with a concentration of 725-735 mg/L at 131˚F / 55˚C and 40-80% relative humidity for 120 minutes. o The wrap was validated for aeration times for EO sterilization of 24 hours at 40.0˚C. Dukal Crepe Paper sterilization wraps are intended to allow sterilization of the enclosed medical device(s), and also to maintain sterility of the enclosed device(s) until opened. The devices are intended for over-the-counter use and are single use disposable sterilization wraps.

Source page: https://510kreport.com/device/K252823
Methodology: https://510kreport.com/methodology