# K140487: Vis-U-All Low Temperature Sterilization Pouch/Tubing

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jul 22, 2014 after 145 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: 3 generations back to K771032 (1977). 6 ancestors in all.
8 later devices descend from it; 2 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)
- K090371: Vis-U-All Low Temperature Tyvek Sterilization Pouch for V-Pro 1 Sterilization System, STERIS Corporation (2009) Summary page 2.

## Most influential descendants
- 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
- K231501: PRO-LITE Sterilization Tray (2023), 0 descendants of its own

## Indications for use
The Vis-U-All Low Temperature Sterilization Pouches/Tubing are sterilization containment pouches for use by health care providers to enclose medical devices to be sterilized in Lumen and Non Lumen Cycles in the V-PRO 60 Low Temperature Sterilization System. The pouches are intend to maintain the sterility of the enclosed devices until used. Pouches are intended to contain devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. Devices with stainless steel lumens and the following minimum internal diameter (ID) and maximum length can be processed in Vis-U-All Low Temperature Sterilization Pouch/Tubing using the Lumen Cycle. single or dual lumen devices 0.77 mm ID and 410 mm in length triple lumen devices 1.2 mm ID and 275 mm in length 1.8 mm ID and 310 mm in length or 2.8 mm ID and 317 mm in length

Source page: https://510kreport.com/device/K140487
Methodology: https://510kreport.com/methodology