# K161910: Cardinal Health Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Apr 20, 2017 after 282 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: 1 generation back to K151445 (2015). 1 ancestor in all.
4 later devices descend from it; 1 cites it directly.
0 of 6 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K151445: Cardinal Health Sterilization Wrap, Cardinal Health200, LLC (2015) Summary page 6.

## Most influential descendants
- K181174: Cardinal Health Sterilization Wrap (2018), 3 descendants of its own
- K233777: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (2024), 1 descendant of its own
- K242208: PRIMED Sterilization Wrap (P100, P200, P300, P400, P500, P600) (2024), 0 descendants of its own
- K222151: Sterilization Wrap (2023), 0 descendants of its own

## Indications for use
The Cardinal Health™ Sterilization Wrap is intended to be used to enclose another medical device that is to be sterilized by a health care provider by using: • Advanced Sterilization Products (ASP) STERRAD® 200 System The wrap is intended to allow sterilization of the enclosed medical device(s) and to maintain sterility of the enclosed devices until it is used. All models of the Cardinal Health™ Sterilization Wrap have been validated for use with the Advanced Sterilization Products (ASP) STERRAD® 200 in Table 1.

Source page: https://510kreport.com/device/K161910
Methodology: https://510kreport.com/methodology