# K083097: Amsco V-Pro 1 Low Temperature Sterilization System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Aug 3, 2009 after 290 days
- Product code: MLR (Sterilizer, Chemical)
- Device class: 2
- Regulation: 21 CFR 880.6860
- Recalls of this device: 1 (0 Class I)
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 1 generation back to K062297 (2007). 1 ancestor in all.
27 later devices descend from it; 6 cite it directly.
0 of 29 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.

## Most influential descendants
- K111810: Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization Units (2011), 18 descendants of its own
- K102394: Amsco V-Pro 1 Low Temperature Sterilization System; Amsco V-Pro 1 Plus Low Temperature Sterilization System (2011), 18 descendants of its own
- K120632: Amsco V-Pro 1 Low/Plus/Max Temperature Sterilization System (2012), 17 descendants of its own
- K131120: Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System (2013), 16 descendants of its own
- K160433: V-PRO® 1 Plus and V-PRO® maX Low Temperature (2016), 8 descendants of its own

## Recalls of this device
- Aug 1, 2011 · Not classified · Z-3041-2011: STERIS learned that Amsco V-PRO 1 and V-PRO 1 Plus Low Temperature Sterilization Systems users may experience premature wear of the vacuum pump and filtering assembly components. Users may also experi

## Indications for use
The Amsco V-PRO 1 Plus Low Temperature Sterilization System, with VAPROX HC Sterilant, is a vaporized hydrogen peroxide sterilizer intended for use in the terminal sterilization of cleaned, rinsed and dried reusable metal and nonmetal medical devices used in healthcare facilities. The two pre-programmed sterilization cycles; the Lumen and the Non Lumen Cycles 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 Plus Low Temperature Sterilizer System's (Lumen Cycle) was cleared under (K062297) can sterilize *' · Instruments with diffusion-restricted spaces such as the hinged portion of forceps and scissors * Medical, devices with a single stainless steel lumen with: o an inside diameter of.1 mnm or larger and a length of a 125 mm or shorter o an insider diameter of 2 mm or larger and a length of 250 mm or shorter o an inside diameter of 3 mm or larger and a length of 400 mm or shorter The validation testing for all lumen sizes was 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 Low Temperature Sterilization System's (Non Lumen Cycle) the subject of this (K083097) can sterilize**: Non-lumened instruments including 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.

Source page: https://510kreport.com/device/K083097
Methodology: https://510kreport.com/methodology