# K231501: PRO-LITE Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Aug 7, 2023 after 75 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: 12 generations back to K844002 (1984). 28 ancestors in all.
No later device cites it as a predicate yet.
0 of 29 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K222440: Vis-U-All Low Temperature Sterilization Pouches/Tubing, PRO-LITE Sterilization Trays, Steris (2022) Summary page 9.

## 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, Fast, and Specialty 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 ate 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 Loads 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: = 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 » 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 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 Toad 2- Non-Tumened 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 Cycles and Intended Tray Loads 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: » 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 » Triple channeled devices with stainless steel lumens +> 1.2 mm ID and <275 mm in length +>1.8 mm ID and <310 mm in length or +>2.8mm ID and <317 mm in length Intended Sterilization Cycles and Intended Tray Loads 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 instruments 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 « Instruments 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 Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, VP0048, VP0049, VP0050 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. V-PRO maX 2 Specialty Cycle: Patient-specific surgical guides (eg. osteotomy, shoulder, hip, knee, spine) or anatomical models fabricated via additive manufacturing (3D printing) processes and intended for single-use during operative procedures.* or Non-lumened instruments including non-lumened general medical instruments, non-lumened rigid, semi-rigid and flexible endoscopes.** *The validation studies were conducted using a validation load consisting of pouched guide(s)/model(s) (with or without tray) for a total weight of 5 Ibs (2.3 kg) 3D printed material. **The validation studies were conducted using a validation load consisting of one pouched intrument try or one pouch with guide(s)/model(s) (with or without tray) for a total weight of 11 Ibs (5kg). Material Manufacturer Specialty Cycle Lumens Surgical Guide Resin Formlabs F >3mmIDand <30 mmL Biomed Amber Resin Formlabs F >3 mmIDand <30 mmL Dental LT Clear V2 Resin Formlabs D >3mmIDand <30 mmL Biomed Clear Resin Formlabs D >3mmIDand <30 mmL Biocompatible Clear MED610 Stratasys E >3mmIDand <20 mmL Biocompatible Opaque Med615RGD Stratasys E >3 mm ID and <20 mm L Veroglaze MED620 Stratasys E >3mmIDand <20 mmL Intended Sterilization Cycles and Intended Tray Loads 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 Loads 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 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: FORM FDA 3881 (6/20) Page 3 of 5 »>1 mm ID and < 500 mm in length « single channel polyethylene and Teflon (polytetrafluoroethylene) > lmm ID and < 850 mm in length Intended Sterilization Cycles and Intended Tray Loads for Tray Models: VP0045, VP0046, VP0047, 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) « > 1mm 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 channe! 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 13x4.5 VP0072 19x4.5 VP0073 25x 4.5 VP0074 13x7.75 VP0075 19x7.75 VP0076 27x7.75 VP0077 12x 11.75 VP0078 25x 11.75 VP0079 25x 14

Source page: https://510kreport.com/device/K231501
Methodology: https://510kreport.com/methodology