# K063159: Sterilox Liquid Chemical Sterilant System

- Pathway: 510(k) (Traditional)
- Applicant: Puricore, Inc.
- Decided: Apr 2, 2007 after 167 days
- Product code: MED (Sterilant, Medical Devices)
- Device class: 2
- Regulation: 21 CFR 880.6885
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 3 generations back to K875280 (1988). 7 ancestors in all.
No later device cites it as a predicate yet.
0 of 8 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K013280: Sterilox Liquid Chemical Sterilant System, Sterilox Technologies, Inc. (2002) Summary page 2.

## Indications for use
SteriloxTM is a high level disinfectant system intended for processing heat sensitive medical devices when used according to the User Manual with an immersion time of ten (10) minutes at 30°C. Sterilox is a single use product generated on site by the Maxigen II (E200) generator for use at its MRC of 400-450 ppm (AFC). The Sterilox high level disinfectant is intended for processing only in an automated endoscope reprocessor or washer disinfector with FDA-cleared capability to maintain the solution temperature at 30°C. The device is intended for use by qualified health care personnel trained in its use.

Source page: https://510kreport.com/device/K063159
Methodology: https://510kreport.com/methodology