# K143333: Revital-Ox RESERT Solution Test Strip

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Apr 14, 2015 after 145 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
Longest line of descent: 4 generations back to K910320 (1991). 6 ancestors in all.
No later device cites it as a predicate yet.
0 of 7 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102296: Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2), STERIS Corporation (2011) Summary page 5.

## Indications for use
The Revital-Ox™ RESERT™ R60 Solution Test Strip is a high level disinfectant concentration monitor dedicated for use with Revital-Ox™ RESERT™ High Level Disinfectant. The purpose of the Revital-Ox™ RESERT™ R60 Solution Test Strip is to determine whether the concentration of hydrogen peroxide, the active ingredient in Revital-Ox™ RESERT™ High Level Disinfectant, is above the minimum recommended concentration (MRC) of 1.5%.

Source page: https://510kreport.com/device/K143333
Methodology: https://510kreport.com/methodology