# K090371: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: May 1, 2009 after 77 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: 2 generations back to K771032 (1977). 5 ancestors in all.
9 later devices descend from it; 1 cites it directly.
0 of 15 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K070765: Vis-U-All II Self Seal Pouch, STERIS Corporation (2007) Summary page 2.
- K071087: Vis-U-All II Heat-Seal Pouch and Tubing, STERIS Corporation (2007) Summary page 2.

## Most influential descendants
- K140487: Vis-U-All Low Temperature Sterilization Pouch/Tubing (2014), 8 descendants of its own
- K160908: Vis-U-All Low Temperature Sterilization Pouch/Tubing (2016), 6 descendants of its own
- K172749: Vis-U-All Low Temperature Sterilization Pouch/Tubing (2018), 5 descendants of its own
- K183401: Vis-U-All Low Temperature Sterilization Pouch/Tubing (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

## Indications for use
The Vis-U-All Low Temperature Tyvek Sterilization Pouches are sterilization containment pouches for use by the health care providers to enclose medical devices to be sterilized in the Amsco V-PRO I Low Temperature Sterilization System. The pouches maintain the sterility of the enclosed device during normal handling and storage until the pouch is opened and the medical device is removed for use.

Source page: https://510kreport.com/device/K090371
Methodology: https://510kreport.com/methodology