# K183402: PRO-LITE Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 1, 2019 after 84 days
- Product code: KCT (Sterilization Wrap Containers, Trays, Cassettes & Other Accessories)
- 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: 10 generations back to K844002 (1984). 16 ancestors in all.
3 later devices descend from it; 1 cites it directly.
0 of 20 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K172755: PRO-LITE Sterilization Trays, 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 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, 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, VP0050, VP0051, VP0052 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 Intended Sterilization Cycles 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 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 Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0050, VP0051, VP0052, VP0053 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. Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050, VP0051, VP0052 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 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 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 Intended Sterilization Cycles and Intended Tray Load for Tray Models: VP0045, VP046, VP0047, VP0048, VP0049, VP0051, VP0052, VP0053 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: • 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 Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the Sterilization Trays. Model Description VP0054 Blank, Tall VP0055 Blank, Short VP0063 3 mm – 7 mm, Tall VP0064 7 mm – 11 mm, Tall VP0065 11 mm – 15 mm, Tall VP0066 15 mm – 19 mm, Tall VP0067 3 mm – 7 mm, Short VP0068 7 mm – 11 mm, Short VP0069 11 mm – 15 mm, Short VP0070 15 mm – 19 mm, Short Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays. Model Description (to fit Length” x Width” Tray) VP0071 13 x 4.5 VP0072 19 x 4.5 VP0073 25 x 4.5 VP0074 13 x 7.75 VP0075 19 x 7.75 VP0076 27 x 7.75 VP0077 12 x 11.75 VP0078 25 x 11.75 VP0079 25 x 14

Source page: https://510kreport.com/device/K183402
Methodology: https://510kreport.com/methodology