# K110954: Arjorad Sterile Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Arjo Wiggins Medical, Inc.
- Decided: Aug 24, 2012 after 507 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 K881471 (1988). 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)
- K092167: Kimguard One-Step Sterilization Wrap, Models KC100, KC200, KC300, KC400, KC500, KC600, Kimberly-Clark Corp. (2009) Summary page 2.

## Indications for use
Used to enclose another medical device that is to be sterilized. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the device until used. ArjoRad Sterilization Wraps will maintain sterility for a maximum period of thirty (30) days. Intended for use with STERRAD 1005S, NX, and IOONX Systems

Source page: https://510kreport.com/device/K110954
Methodology: https://510kreport.com/methodology