# K931202: Sterilization Wrap-Sterisheet

- Pathway: 510(k) (Traditional)
- Applicant: Arjo Wiggins Medical, Inc.
- Decided: Dec 16, 1993 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
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 lists a 510(k) statement for it but has not posted the file, so its predicates are not known.

## Most influential descendants
- K152291: Sterisheet Sterilization Wrap (2015), 3 descendants of its own
- K200335: Sterisheet Sterilization Wrap (2020), 1 descendant of its own
- K252823: Dukal Crepe Paper Sterilization Wrap (2026), 0 descendants of its own
- K170437: Sterisheet Sterilization Wrap (2017), 0 descendants of its own
- K062100: Arjowrap 47/100 and 47/88 (2006), 0 descendants of its own

Source page: https://510kreport.com/device/K931202
Methodology: https://510kreport.com/methodology