# K973981: Safepass Sterilization Pouch

- Pathway: 510(k) (Traditional)
- Applicant: Adroit Medical Systems, Inc.
- Decided: Jan 29, 1998 after 101 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
Longest line of descent: 1 generation back to K921243 (1992). 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)
- K921243: Convertors Sterilization Wrap, Baxter Healthcare Corp (1992) Summary page 1.

## Indications for use
SafePASS Sterilization Pouches are intended for use as sterility barrier packaging in the steam sterilization of various medical devices, kits, instruments, etc. A SafePASS Sterilization Pouch is 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.

Source page: https://510kreport.com/device/K973981
Methodology: https://510kreport.com/methodology