De Novo · Granted
GrantedTerragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terragene S.A. · QVB Biological Sterilization Indicator With Indirect Growth Detection
Granted on Jul 12, 2024 as a new device type through De Novo after a 742-day review. 2 later devices descend from it.
- Decided
- Jul 12, 2024
- Review
- 742 days
- Class
- Class II
- Product code
- QVB
- Recalls
- None
2 later devices descend from it, 2 citing it directly.
- This deviceDEN220042 Terragene Bionova Photon Biological Indicator (BT225); Terragene…Terragene S.A. · 2024
- Descendant · cites it directly · 0 of its ownK251559 InstaTRU Instant Biological Indicator for Steam (IBI-05)True Indicating, LLC · 2026
- Descendant · cites it directly · 0 of its ownK252306 Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix…Steritec Products · 2026
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 |
|---|---|---|---|---|---|
| 0 (this device) | DEN220042 | Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova… | Terragene S.A. | 2024 | — |
| +1 | K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | 2026 | — |
| +1 | K252306 | Verrix EVA™ STEAM Biological Indicator (BI) (Model: 1200), Verrix EVA™ STEAM… | Steritec Products | 2026 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2026 | 2 | 0 |
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 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
- #2 Held for the reportin the report
Does it have a predicate?
De Novo decisions do not claim a predicate device.
What descends from it? (2)
2 later devices cite it directly; ranked here by how many devices descend from each in turn.
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?
- Of its descendants, K251559 (True Indicating, LLC, 2026) has gone furthest, with 0 descendants of its own.
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. 2024, 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?
Terragene® Bionova® Photon Biological Indicator (BT225) is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes. BT225 SCBI is not recommended and should not be used for qualification testing purposes. On each Terragene® Bionova® SCBI is a chemical process indicator that…
Read the full statement (132 words)
Terragene® Bionova® Photon Biological Indicator (BT225) is a 7-second readout Self-Contained Biological Indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes. BT225 SCBI is not recommended and should not be used for qualification testing purposes. On each Terragene® Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.
- Gravity-displacement Steam Sterilization Cycles
132 ºC, 25 minutes
132 ºC, 15 minutes
132 ºC, 10 minutes
135 ºC, 10 minutes
- Dynamic-air-removal Steam Sterilization Cycles
132 ºC, 4 minutes
135 ºC, 3 minutes
Terragene® Bionova® Photon Auto-reader Incubator (BPH) incubates at 60 °C and reads the Terragene® Bionova® Photon SCBIs at the times prescribed in the User Manual.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/DEN220042 · printed Nov 4, 2026
Cite this page
510(k) Report. “DEN220042: Terragene Bionova Photon Biological Indicator (BT225); Terragene Bionova Photon Auto-Reader Incubator (BPH).” Lineage record from FDA De Novo data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/DEN220042
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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