# K233654: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems

- Pathway: 510(k) (Special)
- Applicant: Steris
- Decided: Dec 8, 2023 after 24 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: 5 generations back to K910320 (1991). 9 ancestors in all.
No later device cites it as a predicate yet.
0 of 10 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K173428: VERIFY Chemical Indicator for S40 Sterilant, STERIS Corporation (2018) Summary page 6.

## Indications for use
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle. The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems 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/K233654
Methodology: https://510kreport.com/methodology