De Novo · Granted
GrantedProlystica Pass Thru Disinfectant Wipes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris · SHM Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe
Granted on May 1, 2026 as a new device type through De Novo after a 505-day review.
- Decided
- May 1, 2026
- Review
- 505 days
- Class
- Class II
- Product code
- SHM
- Recalls
- None
De Novo grants create a new device type without a predicate, so this family tree starts here.
Sources: FDA De Novo database (decision fields), the FDA summary (predicates and indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in SHM? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
- Candidate predicates for a device like this, rankedin the report
- Recall history across each candidate’s familyin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
No FDA recall names this device.
No ancestor or descendant has a Class I recall.
How does its category compare?
All SHM devicesSHM Interim Reprocessing Cleaning And Intermediate-Level Disinfection Wipe: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · SHM
1so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · SHM
Too few SHM 510(k)s in any year since 2007 to give a median.
Recalls per year · SHM
No recall names SHM since 2007.
Adverse event reports per year · SHM
No MAUDE report names SHM since 2007.
View these four charts as a table
| Year | Decisions | Median 510(k) review, days | Recalls (Class I) | MAUDE reports |
|---|---|---|---|---|
| 2007 | 0 | — | 0 | 0 |
| 2008 | 0 | — | 0 | 0 |
| 2009 | 0 | — | 0 | 0 |
| 2010 | 0 | — | 0 | 0 |
| 2011 | 0 | — | 0 | 0 |
| 2012 | 0 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 0 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 1 | — | 0 | — |
What is it indicated for?
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.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN240075 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN240075: Prolystica Pass Thru Disinfectant Wipes.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN240075
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Page last updated Nov 3, 2026