# K251048: Rapicide PA High-Level Disinfection Test Strip  Model Ref # = ML02-0118

- Pathway: 510(k) (Special)
- Applicant: STERIS Corporation
- Decided: May 2, 2025 after 29 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 K914145 (1994). 11 ancestors in all.
No later device cites it as a predicate yet.
0 of 12 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- K152394: Rapicide PA High-Level Disinfectant Test Strips, Medivators, Inc. (2016) Summary page 6.

## Indications for use
The RAPICIDE™ PA Test Strips are chemical indicators used after the disinfection cycle to ensure that the RAPICIDE™ PA High-Level Disinfectant solution is met the minimum recommended concentration of 850ppm peracetic acid. The RAPICIDE PA Test Strips are designed for use by trained personnel who reprocess endoscopes and their accessories in facilities where endoscopies are performed.

Source page: https://510kreport.com/device/K251048
Methodology: https://510kreport.com/methodology