# K042580: Tidi Brand Sterilization Wrap

- Pathway: 510(k) (Traditional)
- Applicant: Banta Healthcare Group, Ltd.
- Decided: Nov 17, 2004 after 56 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 K800123 (1980). 1 ancestor in all.
No later device cites it as a predicate yet.
0 of 2 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K800123: Dextex II Sterilization Wrap, Ahlstrom Dexter (1980) Summary page 2.

## Indications for use
Tidi brand Sterilization/CSR Wrap is suitable for both medical and dental facilities as a wrapping material for sterilizing instruments and equipment. Available in numerous sizes, CSR wrap is a single-use product intended for use in steam and ethylene oxide sterilization applications. The wraps maintain their wrapped integrity after sterilization to maintain contents' sterility before use.

Source page: https://510kreport.com/device/K042580
Methodology: https://510kreport.com/methodology