# K111810: Amsco V-Pro 1 and V-Pro 1 Plus Low Temperature Sterilization Units

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Sep 2, 2011 after 67 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: 2 generations back to K062297 (2007). 2 ancestors in all.
18 later devices descend from it; 2 cite 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)
- K062297: VHP 136 Low Temperature Sterilization System, STERIS Corporation (2007) Summary page 2.
- K083097: Amsco V-Pro 1 Low Temperature Sterilization System, STERIS Corporation (2009) Summary page 2.

## Most influential descendants
- 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
- 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

## Indications for use
The Amsco V-PRO I and V-PRO I Plus 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 operate at low pressure and low temperature and are thus suitable for processing medical devices sensitive to heat and moisture. The Amsco V-PRO I Cycle, which is identical to the V-PRO I Plus Lumen Cycle, was cleared under K062297 and 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 mm 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 was cleared under K083097 and 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/K111810
Methodology: https://510kreport.com/methodology