510(k) · Cleared
ClearedVerrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steritec Products · QVB Biological Sterilization Indicator With Indirect Growth Detection
Cleared on Apr 22, 2026 as substantially equivalent to DEN220042 (Terragene S.A., 2024) after a 272-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Apr 22, 2026
- Review
- 272 days
- Class
- Class II
- Product code
- QVB
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to DEN220042 (2024). No later device cites it as a predicate yet.
- Root · 1 generation backDEN220042 Terragene Bionova Photon Biological Indicator (BT225); Terragene…Terragene S.A. · 2024
- This deviceK252306 Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix…Steritec Products · 2026
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova… | Terragene S.A. | 2024 | — |
| 0 (this device) | K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM… | Steritec Products | 2026 | — |
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 QVB? 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 QVB device
- #1 K251559 InstaTRU Instant Biological Indicator for…score 11.5 · 1 generation · no Class I recall
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 |
|---|---|---|---|
| * | DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon…Summary page 6…with Indirect Growth Detection Predicate Device Terragene® Bionova® Photon Biological Indicator (DEN220042) Reference Device: Terragene® Bionova® PCD (PCD225-C) K242453 Description of Device The Verrix EVA STEAM Biological Indi… | 2024 |
| † | K242453 | Terragene® Bionova® Photon Process Challenge Device with unique-point integrator… | 2024 |
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?
- Its one ancestor has no recall.
- 1 other device also cites its predicate DEN220042.
How does its category compare?
All QVB devicesQVB Biological Sterilization Indicator With Indirect Growth Detection: FDA decisions, review times, recalls and adverse event reports over 20 years. 2026, this device’s year, is highlighted.
FDA decisions per year · QVB
2so far in 2026, the most since 2007
2026 to Oct 25, outlined.
Median 510(k) review, days · QVB
Too few QVB 510(k)s in any year since 2007 to give a median.
Recalls per year · QVB
No recall names QVB since 2007.
Adverse event reports per year · QVB
No MAUDE report names QVB 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 | 2 | — | 0 | — |
What is it indicated for?
The Verrix EVA™ STEAM Biological Indicator (BI) 1200 in conjunction with the Verrix EVA™ Auto-reader 1100 is intended for routine monitoring of the steam sterilization process for the following cycles: * 270°F (132°C) 4 minutes dynamic air removal (Pre-Vac) steam sterilization cycles * 275°F (135°C) 3 minutes dynamic air removal (Pre-Vac) steam sterilization cycles When used in conjunction with the Verrix EVA™ Auto-reader 1100, the Verrix EVA™ STEAM…
Read the full statement (200 words)
The Verrix EVA™ STEAM Biological Indicator (BI) 1200 in conjunction with the Verrix EVA™ Auto-reader 1100 is intended for routine monitoring of the steam sterilization process for the following cycles:
* 270°F (132°C) 4 minutes dynamic air removal (Pre-Vac) steam sterilization cycles
* 275°F (135°C) 3 minutes dynamic air removal (Pre-Vac) steam sterilization cycles
When used in conjunction with the Verrix EVA™ Auto-reader 1100, the Verrix EVA™ STEAM Biological Indicator 1200 provides a sterilization confirmation result within 7 minutes.
The Verrix EVA™ STEAM Biological Indicator (BI) 1200 is not recommended and should not be used for qualification testing purposes.
The Verrix EVA™ STEAM Process Challenge Device (PCD) 1300 in conjunction with the Verrix EVA™ Auto-reader 1100 is intended for routine monitoring of the following sterilization cycles:
* 270°F (132°C) 4 minutes dynamic air removal (Pre-Vac) steam sterilization cycles
* 275°F (135°C) 3 minutes dynamic air removal (Pre-Vac) steam sterilization cycles
When used in conjunction with the Verrix EVA™ Auto-Reader 1100, the Verrix EVA™ STEAM Biological Indicator 1200 contained in the PCD provides a sterilization confirmation result within 7 minutes.
The Verrix EVA™ STEAM Process Challenge Device (PCD) 1300 is not recommended and should not be used for qualification testing purposes.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K252306 · printed Nov 6, 2026
Cite this page
510(k) Report. “K252306: Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM Process Challenge Device (PCD) (Model: 1300) combined with Verrix EVA™ Auto-Reader (Model: 1100).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K252306
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Record history
- FDA decision record loaded Oct 30, 2026
- Summary read Oct 30, 2026 (extraction version 2d9447fa9ea4)
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026