# K230558: Revital-Ox PAA High Level Disinfectant Chemical Indicator

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Jul 17, 2023 after 139 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.
No later device cites it as a predicate yet.
0 of 9 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.

## Indications for use
The Revital-Ox PAA High Level Disinfectant Chemical Indicator is designed to determine whether the peracetic acid concentration in the high-level disinfection (HLD) phase of the chosen reprocessing cycle of the enspire 300 Series AER employing Peracetic Acid (Revital-Ox PAA High Level Disinfectant) is above the minimum effective concentration (MEC) of 850 mg/L.

Source page: https://510kreport.com/device/K230558
Methodology: https://510kreport.com/methodology