# K243475: Chemical Indicator for enspire CLCSPS (LCC015)

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: Dec 4, 2024 after 26 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: 6 generations back to K910320 (1991). 10 ancestors in all.
No later device cites it as a predicate yet.
0 of 11 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS, STERIS Corporation (2024) Summary page 7.

## Indications for use
The enspire 3000 Chemical Indicator is a peracetic acid concentration indicator for routine monitoring of the liquid chemical sterilization cycle of the enspire 3000 employing S40 Sterilant. The unprocessed enspire 3000 Chemical Indicator is blue. When exposed in the enspire 3000 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 - 600C, the indicator color changes from the start to the pass color. See reference colors on the bottle.

Source page: https://510kreport.com/device/K243475
Methodology: https://510kreport.com/methodology