# K193066: Steripack cases and Tray Systems

- Pathway: 510(k) (Traditional)
- Applicant: Avalign Technologies, Inc.
- Decided: Aug 6, 2020 after 276 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: 8 generations back to K844002 (1984). 14 ancestors in all.
No later device cites it as a predicate yet.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K163279: Medtronic Transportation/Sterilization Cassettes, Medtronic Sofamor Danek USA, Inc. (2017) Summary page 4.

## Indications for use
The Steripack case and tray system are intended for use in healthcare facilities to organize, enclose, sterilize, transport, and store medical devices and other instrumentation between surgical and other medical uses. The Steripack case and tray system are not intended on their own to maintain sterility; they are intended to be used in conjunction with a legally marketed, validated, FDA-cleared sterilization wrap. Sterilization validation for the worst-case Steripack cases and tray system included surgical instrument such as rongeur forceps, endoscopes, wrenches, cutters, pliers, etc. The Steripack cases and tray system were validated for up to a 9.35 Ib (4.24 kg) load of metal instruments and polymer handled instruments. Sterilization Parameters: Cycle Type: Prevacuum Temperature: 132°C (270°F) Exposure Time: 4 Minutes Pulses: 3 Drying Time: 40 Minutes

Source page: https://510kreport.com/device/K193066
Methodology: https://510kreport.com/methodology