510(k) · Cleared
ClearedInstaTRU Instant Biological Indicator for Steam (IBI-05)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
True Indicating, LLC · QVB Biological Sterilization Indicator With Indirect Growth Detection
Cleared on Jun 18, 2026 as substantially equivalent to DEN220042 (Terragene S.A., 2024) after a 393-day review. Its family tree reaches back 1 generation to 2024.
- Decided
- Jun 18, 2026
- Review
- 393 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 deviceK251559 InstaTRU Instant Biological Indicator for Steam (IBI-05)True Indicating, LLC · 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) | K251559 | InstaTRU Instant Biological Indicator for Steam (IBI-05) | True Indicating, LLC | 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 K252306 Verrix EVA™ STEAM Biological Indicator (BI)…score 11.2 · 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 5…lassification: Class II Medical Device, FDA Product Code QVB, General Hospital Predicate Devices: Terragene Bionova Photon Biological Indicator (BT225) (DEN220042) (Legally Marketed) Description of Device: The True Indicating InstaTRUTM Instant Biological Indicator for Steam (IBI-05)… | 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 True Indicating Instant Biological Indicator for Steam (IBI-05) is a biological indicator inoculated with a minimum of 10”5 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes, and for monitoring processed loads, providing visual confirmation in 20 seconds. The IBI-05 is not recommended and should not be used for qualification testing purposes.…
Read the full statement (107 words)
The True Indicating Instant Biological Indicator for Steam (IBI-05) is a biological indicator inoculated with a minimum of 10”5 viable Geobacillus stearothermophilus bacterial spores and is intended for routine monitoring of the efficacy of steam sterilization processes, and for monitoring processed loads, providing visual confirmation in 20 seconds. The IBI-05 is not recommended and should not be used for qualification testing purposes.
Gravity-displacement Steam Sterilization Cycles:
121 °C for 30 minutes, 132 °C for 25 minutes, 132 °C for 15 minutes, 132 °C for 10 minutes, and 132 °C for 3 minutes.
Dynamic-air-removal Steam Sterilization Cycles:
132 °C for 4 minutes and 135 °C for 3 minutes.
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/K251559 · printed Nov 6, 2026
Cite this page
510(k) Report. “K251559: InstaTRU Instant Biological Indicator for Steam (IBI-05).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K251559
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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