# K112536: Sonicision Sterilization Tray

- Pathway: 510(k) (Abbreviated)
- Applicant: Covidien
- Decided: Apr 19, 2012 after 231 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 K090818 (2009). 1 ancestor in all.
2 later devices descend from it; 1 cites it directly.
0 of 4 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K090818: Karl Storz -Endoscope Sterilization Trays, Models 39402AS, 39301HCTS, 39301BS, KARL STORZ Endoscopy-America, Inc. (2009) Summary page 1.

## Most influential descendants
- K131170: Sonicision Sterilization Tray (2013), 1 descendant of its own
- K151347: MIS Spine Frame Instrument Case (2015), 0 descendants of its own

## Indications for use
The Sonicision Sterilization Tray (SCST) is intended to be used to encase and protect reusable battery packs (SCB) and generators (SCG) 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 STERRADO 100S model and pre-set (non-adjustable) Standard cycle. The tray within its sterile barrier is intended to maintain sterility for up to 30 days.

Source page: https://510kreport.com/device/K112536
Methodology: https://510kreport.com/methodology