# K151445: Cardinal Health Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Cardinal Health200, LLC
- Decided: Dec 21, 2015 after 206 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
No predicates in its family tree.
5 later devices descend from it; 2 cite 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)
- None. FDA has not posted a summary or statement for it, so its predicates are not known.

## Most influential descendants
- K161910: Cardinal Health Sterilization Wrap (2017), 4 descendants of its own
- 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

Source page: https://510kreport.com/device/K151445
Methodology: https://510kreport.com/methodology