# K972035: Sporox Test Strips

- Pathway: 510(k) (Traditional)
- Applicant: Serim Research Corp.
- Decided: Aug 29, 1997 after 88 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: 1 generation back to K910320 (1991). 1 ancestor in all.
9 later devices descend from it; 1 cites it directly.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K910320: Serim Peracetic Acid Reagent Strips, Serim Research Corp. (1991) Summary page 1.

## Most influential descendants
- K081600: Steris Resert XL Test Strip (2008), 8 descendants of its own
- K102217: System 1E Chemical Indicator (2010), 5 descendants of its own
- K173428: VERIFY Chemical Indicator for S40 Sterilant (2018), 3 descendants of its own
- K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS (2024), 1 descendant of its own
- K102296: Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2) (2011), 1 descendant of its own

## Indications for use
SPOROX™ Test Strips provide a rapid, convenient semi-quantitative means of indicating whether effective concentrations of hydrogen peroxide are present in SPOROX® Sterilizing and Disinfecting Solution. The SPOROX™ Test Strips indicate concentrations of hydrogen peroxide but do not confirm disinfection or sterilization.

Source page: https://510kreport.com/device/K972035
Methodology: https://510kreport.com/methodology