De Novo · Granted
GrantedVERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris · SDC Qualitative Cleaning Process Protein Indicator
Granted on Nov 12, 2024 as a new device type through De Novo after a 330-day review.
- Decided
- Nov 12, 2024
- Review
- 330 days
- Class
- Class II
- Product code
- SDC
- 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 SDC? 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 SDC devicesSDC Qualitative Cleaning Process Protein Indicator: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · SDC
1in 2024
2026 to Oct 25, outlined.
Median 510(k) review, days · SDC
Too few SDC 510(k)s in any year since 2007 to give a median.
Recalls per year · SDC
2so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · SDC
No MAUDE report names SDC 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 | 1 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 2 | — |
What is it indicated for?
The VERIFYTM RESI-TESTTM SLIDE-THRU Cleaning Process Protein (CPP) Indicator is a qualitative protein detection test used on a medical device brushable lumen to detect the presence of residual protein in the extracted soils from the brush after cleaning and prior to high level disinfection or sterilization. This is assessed through any solution color change from brown/tan to green/gray/blue. The indicator may become more blue when exposed to higher…
Read the full statement (119 words)
The VERIFYTM RESI-TESTTM SLIDE-THRU Cleaning Process Protein (CPP) Indicator is a qualitative protein detection test used on a medical device brushable lumen to detect the presence of residual protein in the extracted soils from the brush after cleaning and prior to high level disinfection or sterilization. This is assessed through any solution color change from brown/tan to green/gray/blue. The indicator may become more blue when exposed to higher levels of residual protein soils in the extract. Use only with VERIFY RESI-TEST SLIDE-THRU Brush (sold separately) for the lumen size range, as shown below:
- Large brush: 2.8-5.0 mm / 290 cm length
- Medium brush: 1.5-2.6 mm / 220 cm length
- Small brush: 1.0-1.2mm / 150 cm length.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN230085 · printed Nov 6, 2026
Cite this page
510(k) Report. “DEN230085: VERIFY RESI-TEST SLIDE-THRU Cleaning Process Protein (CPP) Indicator.” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/DEN230085
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026