# K062297: VHP 136 Low Temperature Sterilization System

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Oct 4, 2007 after 423 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
No predicates in its family tree.
31 later devices descend from it; 8 cite it directly.
0 of 32 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The FDA summary names its predicate without a number.
- (no number) Sterrad 100S Sterilization System: named in the summary without a submission number

## Most influential descendants
- K083097: Amsco V-Pro 1 Low Temperature Sterilization System (2009), 27 descendants of its own
- K102330: Amsco V-Pro Max Low Temperature Sterilization System (2011), 21 descendants of its own
- K112760: Amsco V-Pro Max Low Temperature Sterilization System (2011), 18 descendants of its own
- 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

## 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 V-PRO 1 Low Temperature Sterilization System and Vaprox® HC Hydrogen Peroxide Sterilant (59%) are intended for use in terminal sterilization of cleaned, rinsed, and dried, reusable metal and nonmetal medical devices used in healthcare facilities. The V-PRO 1 Low Temperature Sterilization System 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 125 mm or shorter o an inside 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.

Source page: https://510kreport.com/device/K062297
Methodology: https://510kreport.com/methodology