# K173428: VERIFY Chemical Indicator for S40 Sterilant

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Mar 2, 2018 after 120 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). 8 ancestors in all.
3 later devices descend from it; 2 cite it directly.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K102217: System 1E Chemical Indicator, STERIS Corporation (2010) Summary page 5.

## Most influential descendants
- K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS (2024), 1 descendant of its own
- K243475: Chemical Indicator for enspire CLCSPS (LCC015) (2024), 0 descendants of its own
- K233654: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems (2023), 0 descendants of its own

## Indications for use
The VERIFY Chemical Indicator for S40 Sterilant is a peracetic acid concentration indicator for routine monitoring of automated STERIS liquid chemical sterilant processing systems that employ S40 Sterilant Concentrate in a controlled cycle. The unprocessed VERIFY Chemical Indicator for S40 Sterilant is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 — 60°C, the indicator changes color from blue through an intermediate beige and then to the endpoint color, pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 sterilant use dilution.

Source page: https://510kreport.com/device/K173428
Methodology: https://510kreport.com/methodology