# K192781: UroLift System Procedure Kit Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: Neotract, Inc.
- Decided: Apr 14, 2020 after 197 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 6.

## Most influential descendants
- K212396: UroLift System Rigid Retrieval Kit Sterilization Tray (2021), 0 descendants of its own

## Indications for use
The UroLift System Procedure Kit Sterilization Tray is intended to be used to enclose and protect surgical instruments used for the UroLift System Procedure for storage and sterilization in a pre-vacuum steam sterilizer. The following instruments are intended to be loaded into the UroLift System Procedure Kit Sterilization Tray: • UL-SCOPE / UL-SCOPE-FE – Cystoscope, 2.9 mm diameter x 365 mm length, 0° angle of view, 85° field of view • UL-SHEATH / UL-SHEATH-FE – Sheath, 20 Fr., with 2 tube connectors (Luer lock and Luer lock with stopcock) • UL-VO / UL-VO-FE – Visual obturator, 20 Fr. The tray by itself is not intended to maintain sterility; it is intended to be used in conjunction with a legally marketed, validated, 510(k) cleared sterilization wrap to maintain sterility of the enclosed instruments when sterilized using the following pre-vacuum steam sterilization cycles: 132 °C Pre-vacuum Steam Cycle Exposure temperature: 270 °F (132 °C) Exposure time: 4 minutes Vacuum dry time: 30 minutes 134 °C Pre-vacuum Steam Cycle Exposure temperature: 273 °F (134 °C) Exposure time: 3 minutes Vacuum dry time: 20 minutes The maximum weight of the tray is 1.8kg / 4lbs.

Source page: https://510kreport.com/device/K192781
Methodology: https://510kreport.com/methodology