# K120947: THS Instrument Tray

- Pathway: 510(k) (Traditional)
- Applicant: Hologic, Inc.
- Decided: Oct 17, 2012 after 202 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). 9 ancestors in all.
30 later devices descend from it; 1 cites it directly.
0 of 40 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.
- K040223: Polyvac Instrument Delivery System, Symmetry Medical USA, Inc. (2004) Summary page 1.

## Most influential descendants
- K152241: Medtronic Transportation/Sterilization Cassettes (2016), 29 descendants of its own
- K163600: Kit Boxes and Kit Plates (2018), 18 descendants of its own
- K180791: Straumann BLX Surgical Cassette (2018), 11 descendants of its own
- K212281: Surgical Trays (2022), 5 descendants of its own
- K181075: PureSet Tray (2018), 5 descendants of its own

## Indications for use
The THS Sterilization Tray is used to enclose, protect, and organize the THS scopes, diagnostic sheath, and associated accessory components, and to facilitate the sterilization process by allowing sterilant penetration and air removal when used in conjunction with an approved sterilization wrap. The THS Instrument tray is not designed to maintain sterility by itself, but when used in conjunction with an approved sterilization wrap sterility of the enclosed medical device is maintained based on the specific time that the maintenance of sterility for that specific wrap as cleared by the FDA. The THS Sterilization Tray is to be sterilized using one of the following cycles: Steam Autoclave Wrapped Pre-Vacuum Parameters: 270'F for 4 minutes Pre-Vacuum Dry Time: 30 minutes Gravity Parameters: 250'F for 30 minutes Gravity Dry Time: 30 minutes

Source page: https://510kreport.com/device/K120947
Methodology: https://510kreport.com/methodology