# K161347: Signia sterilization tray

- Pathway: 510(k) (Traditional)
- Applicant: Covidien
- Decided: Sep 7, 2016 after 114 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: 5 generations back to K844002 (1984). 8 ancestors in all.
5 later devices descend from it; 3 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)
- K130532: Idrive Ultra Sterilization Tray, Covidien, Formerly US Surgical A Divison of Tyco H (2013) Summary page 4.

## Most influential descendants
- 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
- K170226: iTotal Family Reusable Instrument Tray (2017), 0 descendants of its own

## Indications for use
The Signia™ sterilization tray is intended to provide storage for the Signia™ adapters, Signia™ reusable insertion guide and Signia™ manual retraction tool during sterilization, storage and transportation within the hospital environment. The Signia™ 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) Signia™ adapter, one (1) Signia™ reusable insertion guide and one (1) Signia™ manual retraction tool. The tray is intended to allow steam sterilization of the enclosed medical devices. The validated sterilization cycle parameters are as follows: STEAM STERILIZATION Pre-vacuum (HiVac) Steam Cycles Item: Tray with components wrapped or in sterilization container system 132 °C Pre-vacuum (HiVac) Steam Cycles: Exposure temperature 270 °F (132 °C); Exposure time 4 minutes; Vacuum dry time 20 - 40 minutes. 134 °C Pre-vacuum (HiVac) Steam Cycles: Exposure temperature 273 °F (134 °C); Exposure time 3 minutes; Vacuum dry time 20 - 40 minutes.

Source page: https://510kreport.com/device/K161347
Methodology: https://510kreport.com/methodology