# K071087: Vis-U-All II Heat-Seal Pouch and Tubing

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Oct 16, 2007 after 182 days
- Product code: FRG (Wrap, Sterilization)
- 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.
11 later devices descend from it; 2 cite it directly.
0 of 14 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K951295: Sterrad Sterilization Pouch, Advanced Sterilization Products (1995) Summary page 1.
- K771032: Pouches, Peel Open, Breathable, Surgicot, Inc. (1977) 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-All Heat-Seal Pouch and Tubing have been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized in the AMSCO V-Pro 1 Low Temperature Sterilizer. The system is designed to maintain sterility of properly processed medical devices during normal handling and storage until the pouch is opened and the medical device is removed for use.

Source page: https://510kreport.com/device/K071087
Methodology: https://510kreport.com/methodology