# K183301: PRO-LITE Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jan 3, 2019 after 37 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.
No later device cites it as a predicate yet.
0 of 17 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 7.

## 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 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 ≤ 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 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. 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. Instrument organizers are optional accessories intended to stabilize cylindrical medical instruments within the Sterilization Trays. Sterilization mats are optional accessories intended to cushion and stabilize instruments within the Sterilization Trays.

Source page: https://510kreport.com/device/K183301
Methodology: https://510kreport.com/methodology