# K183297: Vis-U-All Low Temperature Sterilization Pouch/Tubing

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 3, 2019 after 37 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: 6 generations back to K771032 (1977). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172749: Vis-U-All Low Temperature Sterilization Pouch/Tubing, STERIS Corporation (2018) Summary page 7.

## 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 in a single or double pouch configuration • trays* containing medical devices in a single or double pouch configuration • small items requiring surface sterilization in a single pouch configuration within a tray* to be sterilized in the Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems. The pouches maintain the sterility of the enclosed devices until used. When used to enclose medical devices, the pouches are intended to contain the devices in such a manner as to leave a minimum of one inch between the devices and seal on all sides. When used to enclose a tray, the tray must fit loosely within the pouch. Intended Sterilization Cycles and Intended Pouch Loads when Medical Devices are: • Directly pouched • Placed inside of a tray* and the tray pouched* V-PRO 60 & s2 Lumen Cycle • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors • Non-lumened devices including non-lumened rigid and semi-rigid endoscopes • Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: • single or dual lumen devices • ≥ 0.77 mm internal diameter (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 V-PRO 60 & s2 Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. V-PRO 60 & s2 Flexible Cycle Load 1: One flexible surgical endoscope or bronchoscope with a light cord (if not integral to endoscope) and mat without any additional load. The flexible endoscope may be a: • single or dual lumen device with lumens that are ≥ 1 mm ID and ≤ 990 mm in length Load 2: Non-lumened devices including non-lumened rigid, semi-rigid, and flexible endoscopes and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. Medical devices, including rigid and semi-rigid endoscopes, with the following dimensions: • ≥ 2 mm ID and ≤ 400 mm in length • ≥ 0.76 mm ID and ≤ 233 mm in length • ≥ 1.0 mm ID and ≤ 254 mm in length V-PRO s2 Fast Cycle • Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes, and non-lumened devices with diffusion-restricted areas such as the hinged portion of forceps or scissors. • Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: • Single or dual channeled devices with stainless steel lumens that are ≥ 0.77 mm ID and ≤ 410 mm in length • Triple channeled devices with stainless steel lumens that are either: • ≥ 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 V-PRO 1, 1 Plus, maX & maX 2 Lumen Cycle • Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors • Non-lumened devices including non-lumened rigid and semi-rigid endoscopes • Medical devices, including single, dual and triple channeled rigid and semi-rigid endoscopes, with the following configurations: • single or dual lumen devices: • ≥ 0.77 mm internal diameter (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 V-PRO 1, 1 Plus, maX & maX 2 Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps and scissors V-PRO 1, 1 Plus, maX & maX 2 Flexible Cycle Load 1: Single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes with a light cord (if not integral to endoscope) and mat with no additional load. The flexible endoscopes may contain either: • a single lumen that is ≥ 1 mm ID and ≤ 1050 mm in length • or two lumens with: • one lumen that is ≥ 1 mm ID and < 990 mm in length • and the other lumen that is ≥ 1 mm ID and ≤ 850 mm in length Load 2: Non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. V-PRO maX 2 Fast Non Lumen Cycle Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel or titanium diffusion-restricted spaces such as the hinged portion of forceps or scissors. *Trays must be legally marketed for use in the V-PRO Low Temperature Sterilization Systems and contain a vent surface area to tray volume ratio ≥0.135 in-1 with the maximum number of instrument organizers installed.

Source page: https://510kreport.com/device/K183297
Methodology: https://510kreport.com/methodology