510(k) · Cleared
ClearedVERIFY Assert Self-Contained Biological Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · OWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid
Cleared on Jun 13, 2018 as substantially equivalent to K162701 (STERIS Corporation, 2017) after a 12-day review. Its family tree reaches back 2 generations to 2013.
- Decided
- Jun 13, 2018
- Review
- 12 days
- Class
- Class II
- Product code
- OWP
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to DEN110006 (2013). No later device cites it as a predicate yet.
- Root · 2 generations backDEN110006 Verify Cronos Self-Contained Biological IndicatorSTERIS Corporation · 2013
- 1 generation backK162701 VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2017
- This deviceK181442 VERIFY Assert Self-Contained Biological IndicatorSTERIS Corporation · 2018
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | DEN110006 | Verify Cronos Self-Contained Biological Indicator | STERIS Corporation | 2013 | — |
| −1 | K162701 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2017 | — |
| 0 (this device) | K181442 | VERIFY Assert Self-Contained Biological Indicator | STERIS Corporation | 2018 | — |
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 OWP? 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
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 |
|---|---|---|---|
| * | K162701 | VERIFY Assert Self-Contained Biological IndicatorSummary page 5…tor with Recombinant-DNA Plasmid (21 CFR 880.2805, OWP) 2. Predicate Device VERIFY Assert Self-Contained Biological Indicator, K162701 3. Description of Device The product is intended to monitor the critical parameters of steam sterilization cycles… | 2017 |
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.
What does this lineage say?
- The line of descent spans 5 years and passes through 1 company; a new generation was cleared every 3.7 years on median.
- None of the 2 ancestors has a recall.
How does its category compare?
All OWP devicesOWP Biological Sterilization Process Indicator With Recombinant-Dna Plasmid: FDA decisions, review times, recalls and adverse event reports over 20 years. 2018, this device’s year, is highlighted.
FDA decisions per year · OWP
1in 2018
2026 to Oct 25, outlined.
Median 510(k) review, days · OWP
177in 2017
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · OWP
No recall names OWP since 2007.
Adverse event reports per year · OWP
2in 2022
MAUDE reports naming product code OWP, not matched to any one device; reports are not rates.
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 | 1 | — | 0 | 0 |
| 2014 | 0 | — | 0 | 0 |
| 2015 | 0 | — | 0 | 0 |
| 2016 | 0 | — | 0 | 0 |
| 2017 | 3 | 177 | 0 | 1 |
| 2018 | 1 | — | 0 | 2 |
| 2019 | 0 | — | 0 | 0 |
| 2020 | 0 | — | 0 | 0 |
| 2021 | 0 | — | 0 | 0 |
| 2022 | 0 | — | 0 | 2 |
| 2023 | 0 | — | 0 | 0 |
| 2024 | 0 | — | 0 | 0 |
| 2025 | 0 | — | 0 | 0 |
| 2026 | 0 | — | 0 | — |
What is it indicated for?
The VERIFY Assert Self-Contained Biological Indicator (SCBI) is for routine monitoring, qualification testing and product testing of the following steam sterilization processes.
Cycle Type Temperature Time
Dynamic Air Removal 270°F (132°C) 4 minutes
Dynamic Air Removal 275°F (135°C) 3 minutes
Gravity 250°F (121°C) 30 minutes
Gravity 270°F (132°C) 15 minutes
When used in conjunction with the Reader for the VERIFY Assert Self-Contained Biological Indicator, the VERIFY Assert Self-Contained Indicator provides a fluorescent result within 40 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K181442 · printed Nov 6, 2026
Cite this page
510(k) Report. “K181442: VERIFY Assert Self-Contained Biological Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K181442
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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