# K180915: Sonicision Reusable Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Jul 17, 2018 after 99 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: 6 generations back to K844002 (1984). 9 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K161347: Signia sterilization tray, Covidien (2016) Summary page 4.

## Most influential descendants
- K243589: PAL Sterilization Case (2025), 0 descendants of its own

## Indications for use
The Sonicision™ reusable sterilization tray is intended to provide storage for the Sonicision™ reusable generator and Sonicision™ reusable battery insertion guides during sterilization, storage, and transportation within the hospital environment. The Sonicision™ reusable sterilization tray is only intended to maintain sterility of the enclosed components during autoclave sterilization when used in conjunction with an FDA-cleared sterilization wrap or rigid container (validated with Aesculap™* rigid container model JN741/JK789). The sterilization tray has only been evaluated for a non-stacked configuration. The validated sterilization cycle parameters are as follows: Steam Sterilization Cycles Cycle Type | Exposure Temperature | Exposure Time (minutes) | Minimum Dry Time (minutes) | Compatible Sterile Barriers Pre-vacuum | 132 °C (270 °F) | 4 | 40 | Wrap(s) and rigid container Pre-vacuum | 135 °C (275 °F) | 3 | 40 | Wrap(s) and rigid container Gravity | 132 °C (270 °F) | 15 | 40 | Wrap(s) Gravity | 135 °C (275 °F) | 10 | 30 | Wrap(s) Due to variations in autoclave sterilization equipment, actual dry times may vary from the minimum dry times validated for this product. Validated with Aesculap Rigid Container model JN741/JK789

Source page: https://510kreport.com/device/K180915
Methodology: https://510kreport.com/methodology