# K172292: SALUS - Hygiene Instrument Reprocessing Container

- Pathway: 510(k) (Abbreviated)
- Applicant: Scican, Ltd.
- Decided: Nov 24, 2017 after 116 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
The SALUS® - Hygiene is a device intended to be used to enclose another medical device that is to be sterilized by a health care provider. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used. The SALUS® - Hygiene is a reusable instrument reprocessing container intended to enclose and organize instruments that are designed to withstand steam sterilization and to maintain sterility of the reusable instruments during storage. The SALUS - Hygiene is suitable for use in dynamic air removal steam sterilizers. Please refer the chart below for validated sterilization cycles.

Source page: https://510kreport.com/device/K172292
Methodology: https://510kreport.com/methodology