# K092745: Vis-U-All Low Temperature Tyvek Sterilization Pouch for Ethylene Oxide, Models: Self and Heat Seal Pouches, Heat Seal TU

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Nov 19, 2010 after 437 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- Device class: 2
- Regulation: 21 CFR 880.6850
- Recalls of this device: 1 (0 Class I)
- 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.
1 later device descends from it; 1 cites it directly.
0 of 7 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
- K231500: Vis-U-All Low Temperature Sterilization Pouches (2023), 0 descendants of its own

## Recalls of this device
- Aug 2, 2012 · Class III · Z-2325-2012: On 7/20/2012 the firm became aware that a lot of tubing was distributed by the supplier after it was rejected by Steris due to failing process indicators.

## Indications for use
The Vis-U-AI1 Low Temperature Tyvek Sterilization Pouch for ethylene oxide has been qualified by STERIS Corporation as suitable for use by health care providers to enclose and seal other medical devices to be sterilized by ethylene oxide (ETO). The Vis-U-AlI Low Temperature Tyvek Sterilization Pouch for ethylene oxide 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. Pouch and Tubing Sizes for STERIS Vis-U-All Low Temperature Products The following are the validation test conditions: * 1 hour exposure; at 130(+5) OF*, >30% RH using 100% ETO (750-790 mg/L); * 4.5 hour exposure; at 100(±5) OF*, >30% RIH using 100% ETO (750-790 mg/L); ±5 0F is during sterilization phase following an equilibration period of 10% of exposure time. The ethylene oxide process indicator is intended to be used by a health care provider with the Vis-U-AlI Low Temperature Tyvek Sterilization Pouches to distinguish between processed and unprocessed units.

Source page: https://510kreport.com/device/K092745
Methodology: https://510kreport.com/methodology