# DEN240075: Prolystica Pass Thru Disinfectant Wipes

- Pathway: De Novo (Direct)
- Applicant: Steris
- Decided: May 1, 2026 after 505 days
- Product code: SHM (Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe)
- Device class: 2
- Regulation: 21 CFR 880.6891
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
No later device cites it as a predicate yet.
0 of 1 device in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. De Novo decisions do not claim a predicate device.

## Indications for use
Prolystica Pass Thru Disinfectant Wipes are a ready-to-use (RTU) one-step cleaner and intermediate level disinfectant. They are intended for use in hospitals and other healthcare facilities to clean and intermediate level disinfect non-submersible and/or heat-sensitive critical and semi-critical medical devices or medical device components. When properly used, the medical device will be intermediate level disinfected and rendered "safe to handle". Not intended for use on flexible endoscopes. Not intended for use as a terminal sterilization or high-level disinfection (HLD) processing step for critical and semi-critical devices.

Source page: https://510kreport.com/device/DEN240075
Methodology: https://510kreport.com/methodology