# K130532: Idrive Ultra Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Covidien, Formerly US Surgical A Divison of Tyco H
- Decided: May 30, 2013 after 90 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: 4 generations back to K844002 (1984). 7 ancestors in all.
6 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K012105: Polyvac Surgical Instrument Delivery System, Symmetry Medical, Inc. (2002) Summary page 1.
- K993535: Metapak Multi-Purpose Instrument Tray, Riley Medical, Inc. (2001) Summary page 1.

## Most influential descendants
- K161347: Signia sterilization tray (2016), 5 descendants of its own
- K192781: UroLift System Procedure Kit Sterilization Tray (2020), 1 descendant of its own
- K180915: Sonicision Reusable Sterilization Tray (2018), 1 descendant of its own
- K243589: PAL Sterilization Case (2025), 0 descendants of its own
- K212396: UroLift System Rigid Retrieval Kit Sterilization Tray (2021), 0 descendants of its own

## Indications for use
The iDrive™ Ultra sterilization tray (IDRVTRAY) is intended to provide storage for the iDrive™ Ultra powered stapling system during sterilization, storage and transportation within the hospital environment. The iDrive™ Ultra Sterilization Tray is only intended to maintain sterility of the enclosed devices if it is used in conjunction with an FDA cleared sterilization wrap and has only been evaluated for a non-stacked configuration. The tray can contain at a maximum: one (1) iDrive™ Ultra powered handle, two (2) Endo GIA™ adapters, two (2) iDrive™ battery insertion guides and one (1) iDrive™ Ultra manual adapter tool. The tray is intended to be sterilized by the following cycles: Prevacuum Steam Cycles 132°C for 4 minutes 134°C for 3 minutes Vacuum Dry: 20 minutes

Source page: https://510kreport.com/device/K130532
Methodology: https://510kreport.com/methodology