# K131120: Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jul 16, 2013 after 85 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 6 generations back to K020875 (2003). 11 ancestors in all.
16 later devices descend from it; 3 cite it directly.
0 of 28 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K062297: VHP 136 Low Temperature Sterilization System, STERIS Corporation (2007) Summary page 2.
- K102394: Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature Sterilization System, STERIS Corporation (2011) Summary page 2.
- K111810: Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization Units, STERIS Corporation (2011) Summary page 4.
- K120632: Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System, STERIS Corporation (2012) Summary page 2.
- K083097: Amsco V-Pro 1 Low Temperature Sterilization System, STERIS Corporation (2009) Summary page 2.
- K102330: Amsco V-Pro Max Low Temperature Sterilization System, STERIS Corporation (2011) Summary page 2.
- K112760: Amsco V-Pro Max Low Temperature Sterilization System, STERIS Corporation (2011) Summary page 4.

## Most influential descendants
- K160433: V-PRO® 1 Plus and V-PRO® maX Low Temperature (2016), 8 descendants of its own
- K162413: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (2017), 7 descendants of its own
- K172319: AMSCO V-PRO 1 Low Temperature Sterilization System, AMSCO V-PRO 1 Plus Low Temperature Sterilization System, V-PRO maX Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (2018), 5 descendants of its own
- K141163: Sterizone Sterilizer (2014), 5 descendants of its own
- K182568: V-PRO s2 Low Temperature Sterilization System, V-PRO 60 Low Temperature Sterilization System (2019), 4 descendants of its own

## Indications for use
The Amsco V-PRO 1, V-PRO I Plus and V-PRO maX Low Temperature Sterilization Systems, with VAPROX HC Sterilant, are vaporized hydrogen peroxide sterilizers intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The pre-programmed sterilization cycles (Lumen Cycle, Non Lumen Cycle, and Flexible Cycle) operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. The Amsco V-PRO 1, V-PRO I Plus and V-PRO maX Low Temperature Sterilization Systems' Lumen Cycle, the subject of this submission, can sterilize: • Lumened and non-lumened instruments 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: • single channeled devices with a stainless lumen that is > 0.77 mm internal diameter (ID) and < 500 mm in length • dual channeled devices with stainless steel lumens that are 0.77 mm ID and < 527 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 The validation studies for all channel/lumen configurations were conducted using a maximum of twenty (20) lumens per load. Hospital loads should not exceed the maximum number of lumens validated by this testing. The validation studies were performed using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. The Amsco V-PRO 1 Plus and V-PRO maX Low Temperature Sterilization Systems' Non Lumen Cycle, cleared under K083097, K102394 and K111810, can sterilize: Non-lumened instruments including non-lumened rigid, semi-rigid and flexible endoscopes and non-lumened instruments with stainless steel diffusion-restricted areas such as the hinged portion of forceps or scissors. The validation studies were conducted using a validation load consisting of two instrument trays and two pouches for a total weight of 19.65 lbs. The Amsco V-PRO maX Low Temperature Sterilization System's Flexible Cycle, cleared under K102330 and K112760, can sterilize single or dual lumen surgical flexible endoscopes (such as those used in ENT, Urology and Surgical Care) and bronchoscopes in either of two load configurations: 1. Two flexible endoscopes 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 < 998 mm in length • and the other lumen that is > 1 mm ID and < 850 mm in length The validation studies were conducted with two flexible endoscopes, each packaged into a tray with silicone mat and light cord (if not integral to endoscope). 2. One flexible endoscope with a light cord (if not integral to endoscope) and mat and additional non-lumened instruments including instruments with diffusion-restricted areas such as the hinged portion of forceps or scissors. The flexible endoscope can 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 < 998 mm in length • and the other lumen that is > 1 mm ID and < 850 mm in length The validation studies were conducted with a flexible endoscope in a tray with silicone mat and light cord (if not integral to endoscope). Also included in the load were an additional instrument tray and one pouch for a total load weight of 24.0 lbs.

Source page: https://510kreport.com/device/K131120
Methodology: https://510kreport.com/methodology