# K222440: Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays

- Pathway: 510(k) (Special)
- Applicant: Steris
- Decided: Sep 9, 2022 after 28 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: 11 generations back to K844002 (1984). 27 ancestors in all.
2 later devices descend from it; 2 cite it directly.
0 of 30 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K183401: Vis-U-All Low Temperature Sterilization Pouch/Tubing, STERIS Corporation (2019) Summary page 12.
- K183402: PRO-LITE Sterilization Tray, STERIS Corporation (2019) Summary page 22.

## Most influential descendants
- 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. 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 * Non-lumened devices 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: o single or dual lumen devices > 0.77 mm internal diameter (ID) and <410 mm in length > 1.8 mm ID x < 542 mm in length o 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 configurations: >0.76 mm ID and < 233 mm in length > 1.0 mm ID and <254 mm in length > 1.8 mm ID and < 542 mm in length V-PRO s2 Fast Cycle * Non-lumened devices including non-lumened rigid and semi-rigid and flexible endoscopes and non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors. » Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: o single or dual lumen devices >0.77 mm ID and <410 mm in length > 1.8 mm ID x < 542 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 * Non-lumened devices 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 or triple channeled stainless steel lumens that are: > 0.77 mm ID and < 527 mm in length > 0.8 mm ID and < 542 mm in length > 0.48 mm ID and < 100 mm in length » Medical devices with Dead end lumens that are > 1.3 mm ID and < 73 mm in length * Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: >3 mm ID and <298 mm in length >4 mm ID and < 424 mm in length V-PRO 1, 1 Plus, maX & maX2 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 maX and 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 or dual channel lumen that is > 1 mm ID and < 1050 mm in length Load 2: * 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 » Single, dual or triple channel stainless steel lumen that is > 0.48 mm ID and < 100 mm in length. 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 diffusion-restricted spaces such as the hinged portion of forceps and scissors. STERRAD 100S Default Cycle Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Metal and nonmetal 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 Scope 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: [J 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 sterilization only) 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 [J accessory devices that are normally connected to a flexible endoscope during use [J flexible endoscopes without lumens The PRO-LITE Sterilization Trays are used to contain medical devices for sterilization in the following Cycles: * 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 » Standard, Flex Scope, Express and DUO Cycles of the STERRAD 100NX and 100NX with ALLClear Technology Sterilizers *STERRAD and ALLClear are trademarks of Advanced Sterilization Products Prior to placing in the Sterilizer, the trays must either be: » wrapped with a legally marketed sterilization wrap for use in the Sterilizers listed above or » placed inside a legally marketed pouch for enclosing trays in the Sterilizers listed above. The PRO-LITE Sterilization Trays are not intended to maintain sterility; they are intended to be used in conjunction with a validated, FDA-cleared sterilization wrap or pouch in order to maintain sterility of the enclosed medical instruments. Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052 V-PRO 60 and s2 Lumen Cycle: * Non-lumened devices 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: o Single or dual channeled devices with stainless steel lumens that are: > 0.77 mm ID and <410 mm in length > 1.8 mm ID x < 542 mm in length o Triple channeled devices with stainless steel lumens that are: > 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 and 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 and 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 configurations: >0.76 mm ID and < 233 mm in length > 1.0 mm ID and <254 mm in length > 1.8 mm ID and < 542 mm in length Intended Sterilization Cycle and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049 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 and scissors. » Medical devices (including single, dual and triple channeled rigid and semi-rigid endoscopes) with the following configurations: o Single or dual channeled devices with stainless steel lumens > 0.77 mm ID and <410 mm in length > 1.8 mm ID and < 542 mm in length o 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 > 2.8 mm ID and <317 mm in length Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052, VP0053 V-PRO 1, 1 Plus, maX, and maX 2 Lumen Cycle: * Non-lumened devices with diffusion-restricted spaces such as the hinged portion of forceps and scissors » Medical devices, including single, dual or triple channeled stainless steel lumens that are: > 0.77 mm ID and < 527 mm in length > 0.8 mm ID and <542 mm in length > 0.48 mm ID and < 100 mm in length » Medical devices with dead end stainless steel lumens that are > 1.3 mm ID and < 73 mm in length * Devices with rigid non-metallic lumens (such as those used in endoscope sheaths, take-apart forceps and trocars) that are: >3 mm ID and <298 mm in length >4 mm ID and <424 mm in length V-PRO 1 Plus, maX, and maX 2 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 maX, and 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 or dual lumen that is > 1 mm ID and < 1050 mm in length. Load 2: * 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 » Single, dual or triple channel stainless steel lumens that are > 0.48 mm ID and < 100 mm in length 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 diffusion-restricted spaces such as the hinged portion of forceps and scissors. Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052 STERRAD 100S Default Cycle: Metal and nonmetal medical devices including instruments which have diffusion-restricted spaces, such as the hinged portion of forceps and scissors. Metal and nonmetal 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 Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0048, VP0049 STERRAD NX and NX with ALLClear Technology Standard Cycle: Metal and non-metal 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 STERRAND NX and NX with ALLClear Technology Advanced Cycle: Metal and non-metal 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: o a single stainless steel lumen with: > 1 mm ID and < 500 mm in length o single channel polyethylene and Teflon (polytetrafluoroethylene) > lmm ID and < 850 mm in length Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0048, VP0049, VP0051, VP0052, VP0053 STERRAD 100NX and 100NX with ALLClear Technology Standard Cycle: Metal and nonmetal medical devices including instruments with 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 Scope 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) > Imm ID and < 850 mm in length STERRAD 100NX and 100NX with ALLClear Technology Express Cycle: Metal and nonmetal 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/K222440
Methodology: https://510kreport.com/methodology