510(k) · Cleared
ClearedVERIFY Spore Test Strip for S40 Sterilant
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · OVY Liquid Chemical Processing System
Cleared on May 29, 2018 as substantially equivalent to DEN110002 (STERIS Corporation, 2012) after an 89-day review. Its family tree reaches back 1 generation to 2012. 2 later devices descend from it.
- Decided
- May 29, 2018
- Review
- 89 days
- Class
- Class II
- Product code
- OVY
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN110002 (2012). 2 later devices descend from it, 1 citing it directly.
- Root · 1 generation backDEN110002 System 1E Process Biological Monitoring KitSTERIS Corporation · 2012
- This deviceK180553 VERIFY Spore Test Strip for S40 SterilantSTERIS Corporation · 2018
- Descendant · cites it directly · 1 of its ownK231746 VERIFY Spore Test Strip for S40 Sterilant ConcentrateSTERIS Corporation · 2023
- Descendant · 2 generations on · 0 of its ownK233682 VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATESTERIS Corporation · 2023
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN110002 | System 1E Process Biological Monitoring Kit | STERIS Corporation | 2012 | — |
| 0 (this device) | K180553 | VERIFY Spore Test Strip for S40 Sterilant | STERIS Corporation | 2018 | — |
| +1 | K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | STERIS Corporation | 2023 | — |
| +2 | K233682 | VERIFY SPORE TEST STRIP for S40 STERILANT CONCENTRATE | STERIS Corporation | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2023 | 2 | 0 |
Sources: FDA 510(k) 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 OVY? A 510(k) Report weighs predicate choices, recall history and review times for a new device like this one.
Top candidate predicates for a new OVY device
- #1 K231746 VERIFY Spore Test Strip for S40 Sterilant…score 9.3 · 2 generations · no Class I recall
- #2 Held for the reportin the report
What was it cleared against? (1)
Devices the submitter claimed this one is substantially equivalent to (*), and reference devices cited for a specific test or feature (†), as written in the FDA summary.
| Type | Number | Device | Decided |
|---|---|---|---|
| * | DEN110002 | System 1E Process Biological Monitoring KitSummary page 5…uid Chemical Processing System Classification 21 CFR 880.6887 Product Code OVY 2. Predicate Device VERIFY® Spore Test Strip for S40 – DEN110002 (K100049) 3. Device Description The VERIFY® Spore Test Strip for S40 Sterilant consists of a 1 ⅜ in. x ¼ in. filter… | 2012 |
What descends from it? (2)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K231746 | VERIFY Spore Test Strip for S40 Sterilant Concentrate | 2023 | 1 |
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.
What does this lineage say?
How does its category compare?
All OVY devicesOVY Liquid Chemical Processing System: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OVY
2in 2023
2026 to Oct 25, outlined.
Median 510(k) review, days · OVY
Too few OVY 510(k)s in any year since 2007 to give a median.
Recalls per year · OVY
No recall names OVY since 2007.
Adverse event reports per year · OVY
No MAUDE report names OVY 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 | 1 | — | 0 | 0 |
| 2013 | 0 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 0 | — | 0 | 0 |
| 2018 | 1 | — | 0 | 0 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 0 |
| 2023 | 2 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VERIFY® Spore Test Strip for S40 Sterilant is intended to provide users with a means to assess spore kill by S40 sterilant use dilution in the STERIS automated Liquid Chemical Sterilant Processing Systems (SYSTEM 1E Liquid Chemical Sterilant Processing System and SYSTEM 1 endo Liquid Chemical Sterilant Processing System). A “no growth” result from the VERIFY Spore Test Strip for S40 Sterilant after 24 hours of incubation indicates that the liquid chemical sterilization process achieved the conditions necessary to kill at least 1 x 10E5 viable spores (5 logs) on the test strip. It does not confirm the expected full performance of the liquid chemical sterilization cycle.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K180553 · printed Nov 6, 2026
Cite this page
510(k) Report. “K180553: VERIFY Spore Test Strip for S40 Sterilant.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K180553
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026