# K222151: Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Kenpax International Limited
- Decided: Mar 23, 2023 after 246 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: 10 generations back to K881471 (1988). 17 ancestors in all.
No later device cites it as a predicate yet.
0 of 18 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K181174: Cardinal Health Sterilization Wrap, Cardinal Health200, LLC (2018) Summary page 8.

## Indications for use
The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed device(s) until used up to 365 days post sterilization. Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider using: a) 100% ethylene oxide (EO) with a concentration of 725 - 735 mg/l at 131 °F/55°C and 40%-80% relative humidity for 60 minutes. b) Exhausting the EO gas vacuum depth: 157 mBar to 160 mBar c) Aeration time : 12 hours d) Aeration temperature: 55°C e) Aeration pressure : 841 mBar to 864 mBar Suggestions for the packaging content are given in table, A single layer of wrapping needs to be packaged in two sheets.

Source page: https://510kreport.com/device/K222151
Methodology: https://510kreport.com/methodology