# K070765: Vis-U-All II Self Seal Pouch

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Oct 12, 2007 after 206 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: 1 generation back to K771032 (1977). 2 ancestors in all.
12 later devices descend from it; 3 cite 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)
- K771032: Pouches, Peel Open, Breathable, Surgicot, Inc. (1977) Summary page 1.
- K820302: Surgipeel Self-Seal Packaging System, Surgicot, Inc. (1982) Summary page 1.

## Most influential descendants
- K090371: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System (2009), 9 descendants of its own
- 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

## Indications for use
The Vis-U-AIl Self Seal Pouch is a sterilization containment pouch designed for devices to be sterilized by the AMSCO V-Pro 1 Low Temperature Sterilization System. It is intended to allow sterilization of the enclosed medical device and also to maintain sterility of the enclosed device until used.

Source page: https://510kreport.com/device/K070765
Methodology: https://510kreport.com/methodology