# K160912: Sterilization Tray

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Oct 7, 2016 after 189 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: 8 generations back to K844002 (1984). 14 ancestors in all.
6 later devices descend from it; 1 cites it directly.
0 of 21 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K140494: V-Pro Sterilization Tray/ Sterilization Mat, STERIS Corporation (2014) Summary page 6.

## Most influential descendants
- K172755: PRO-LITE Sterilization Trays (2018), 5 descendants of its own
- K183402: PRO-LITE Sterilization Tray (2019), 3 descendants of its own
- 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 Sterilization Trays are used to contain medical devices for sterilization in the Lumen, Non Lumen and Flexible 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 V-PRO Low Temperature Sterilization Systems or placed inside a legally marketed pouch for enclosing trays in the V-PRO Low Temperature Sterilization Systems. The 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. Model Number (size LxWxH in inches) Intended Sterilization Cycles Intended Tray Load VP0045 (13x4.5x2.25), VP0046 (19x4.5x2.25), VP0047 (25x4.5x2.25), VP0048 (13x7.75x2.25), VP0049 (19x7.75x2.25), VP0050 (27x7.75x4), VP0051 (12x11.75x4), VP0052 (25x11,75x4.5), VP0053 (25x14x5) V-PRO 60 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 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 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 60 Flexible Cycle: 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. V-PRO 1, 1 Plus & maX 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 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 Non Lumen Cycle: Non-lumened devices including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened devices with stainless steel diffusion-restricted spaces such as the hinged portion of forceps and scissors. V-PRO maX 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. 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/K160912
Methodology: https://510kreport.com/methodology