# K172755: PRO-LITE Sterilization Trays

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Feb 9, 2018 after 150 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: 9 generations back to K844002 (1984). 15 ancestors in all.
5 later devices descend from it; 2 cite it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K160912: Sterilization Tray, STERIS Corporation (2016) Summary page 7.

## Most influential descendants
- K183402: PRO-LITE Sterilization Tray (2019), 3 descendants of its own
- K222440: Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays (2022), 2 descendants of its own
- K231501: PRO-LITE Sterilization Tray (2023), 0 descendants of its own
- K231500: Vis-U-All Low Temperature Sterilization Pouches (2023), 0 descendants of its own
- K183301: PRO-LITE Sterilization Tray (2019), 0 descendants of its own

## Indications for use
The PRO-LITETM Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen, Flexible, and Fast Non Lumen Cycles of the V-PRO Low Temperature Sterilization Systems. Prior to placing in the Sterilizer, the trays must either be: wrapped with a legally marketed sterilization wrap for use in the V-PRO Low Temperature Sterilization Systems or placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments.

Source page: https://510kreport.com/device/K172755
Methodology: https://510kreport.com/methodology