# K140498: V-Pro 60 Low Temperature Sterilization System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jul 24, 2014 after 147 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: 7 generations back to K020875 (2003). 12 ancestors in all.
No later device cites it as a predicate yet.
0 of 13 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K131120: Amsco V-Pro 1 Low, V-Pro 1 Plus, V-Pro Max Low Temperature Sterilization System, STERIS Corporation (2013) Summary page 2.

## Indications for use
The V-PRO 60 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 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 V-PRO 60 Sterilizer's Lumen Cycle can sterilize: 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: a. Single or dual lumen devices with stainless steel lumens that are 0.77 mm (-1/32") internal diameter (ID) and 410 mm (16-9/64") in length b. Triple lumen devices with stainless steel lumens that are 1.2 mm (-3/64") ID and 275 mm (-10-55/64") in length; 1.8 mm (-5/64") ID and 310 mm (-12-13/64") in length; or 2.8 mm (-7/64") ID and 317 mm (12-31/64") in length The validation studies for all lumen configurations were conducted using a maximum of twelve (12) 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 one instrument tray with instrument organizers and mat and two pouches for a total weight of 11 lbs (5.0 kg). The V-PRO 60 Sterilizer's Non Lumen Cycle can sterilize: 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. The validation studies were performed using a validation load consisting of one instrument tray with instrument organizers and mat and one pouch for a total weight of 12 lbs (5.4 kg). The V-PRO 60 Sterilizer's Flexible Cycle can sterilize: 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 (-3/64") ID and < 990 mm (38-63/64") in length. The validation studies were conducted with one flexible endoscope, packaged into a tray with silicone mat, instrument organizers and light cord (if not integral to scope) and no additional load.

Source page: https://510kreport.com/device/K140498
Methodology: https://510kreport.com/methodology