# K020612: Sultan Sporox Test Vial, Model 75195

- Pathway: 510(k) (Traditional)
- Applicant: Sultan Chemists, Inc.
- Decided: May 7, 2002 after 71 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
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. FDA’s file for it is a 510(k) statement, which names no predicate.

## Indications for use
Sultan Sporox Test Vials are indicated as a rapid, qualitative method for determining if an effective concentration of hydrogen peroxide is present in Sporox Sterilizing and Disinfecting Soution. The Sporox Test Vials indicate the concentration of hydrogen peroxide but do not confirm disinfection or sterilization.

Source page: https://510kreport.com/device/K020612
Methodology: https://510kreport.com/methodology