# K131170: Sonicision Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly Valleylab, A Division of Tyco H
- Decided: Aug 28, 2013 after 126 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: 7 generations back to K844002 (1984). 15 ancestors in all.
1 later device descends from it; 1 cites it directly.
0 of 17 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K112536: Sonicision Sterilization Tray, Covidien (2012)
- K070769: VHP 136 Tray, STERIS Corporation (2007) Summary page 1.
- K103213: Finess Endoscope Sterilization Tray, Entellus Medical, Inc. (2011) Summary page 1.

## Most influential descendants
- K151347: MIS Spine Frame Instrument Case (2015), 0 descendants of its own

## Indications for use
The Sonicision Sterilization Tray is intended to be used to encase and protect reusable battery packs and generators of the Sonicision system during sterilization and storage. The tray containing up to one generator and one battery pack (maximum load) can be used with the following models and pre-set (non-adjustable) cycles. STERRAD 100S — Standard STERRAD NX — Standard STERRAD 100NX — Standard STERIS Amsco V-PRO I — Lumen STERIS Amsco V-PRO I Plus — Lumen STERIS Amsco V-PRO maX — Lumen Maintenance of sterility of the content within the tray is based on demonstrated performance of the sterilization wrap or pouch used to encase the tray.

Source page: https://510kreport.com/device/K131170
Methodology: https://510kreport.com/methodology