# K183401: Vis-U-All Low Temperature Sterilization Pouch/Tubing

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 1, 2019 after 84 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.
3 later devices descend from it; 1 cites it directly.
0 of 13 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 8.

## Most influential descendants
- 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
- K231500: Vis-U-All Low Temperature Sterilization Pouches (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 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 NOTE: Trays must be legally marketed for use in the V PRO Low Temperature or STERRAD Sterilization Systems and contain a vent surface area to tray volume ratio ≥ 0.135 in-1 with the maximum number of instrument organizers installed. and to be sterilized in the: • Lumen, Non Lumen, Flexible, Fast Non Lumen and Fast Cycles of the V-PRO® Low Temperature Sterilization Systems • Default Cycle of the STERRAD 100S Sterilizer • Standard and Advanced Cycles of the STERRAD NX and NX with ALLClear Technology Sterilizers • Express, Standard, Flex Scope, and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers *STERRAD and ALLClear are trademarks of Advanced Sterilization Products 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 ≤ 527 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 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 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 and scissors. STERRAD 100S Default Cycle • Metal and non-metal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Metal and non metal lumened instruments with: • ≥ 6 mm ID and ≤ 310 mm in length • Medical devices with a single stainless steel lumen with: • ≥ 1 mm ID and ≤ 125 mm in length • ≥ 2 mm ID and ≤ 250 mm in length • ≥ 3 mm ID and ≤ 400 mm in length STERRAD NX and NX with ALLClear Technology Standard Cycle • Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Medical devices with a single stainless steel lumen with: • ≥ 1 mm ID and ≤ 150 mm in length • ≥ 2 mm ID and ≤ 400 mm in length STERRAD NX and NX with ALLClear Technology Advanced Cycle • Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Medical Devices, including most flexible endoscopes, with: • a single stainless steel lumen with: • ≥ 1 mm ID and ≤ 500 mm in length • single channel polyethylene and Teflon (polytetrafluoroethylene): • ≥ 1 mm ID and ≤ 850 mm in length STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle • Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Medical devices with a single stainless steel lumen with: • ≥ 0.7 mm ID and ≤ 500 mm in length STERRAD 100NX and 100NX with ALLClear Technology Flex Cycle • Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. • Medical Devices, including most flexible endoscopes, with: • Single channel polyethylene and Teflon (polytetrafluoroethylene) • ≥ 1 mm ID and ≤ 850 mm in length STERRAD 100NX and 100NX with ALLClear Technology Express Cycle Metal and nonmetal medical devices surfaces and instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. STERRAD 100NX and 100NX with ALLClear Technology Duo Cycle • Medical devices including: • most flexible endoscopes with a single channel of polyethylene and Teflon (polytetrafluoroethylene) with ≥ 1 mm ID and ≤ 875 mm in length • accessory devices that are normally connected to a flexible endoscope during use • flexible endoscopes without lumens

Source page: https://510kreport.com/device/K183401
Methodology: https://510kreport.com/methodology