510(k) · Cleared
ClearedTerragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40)
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Terragene S.A. · FRC Indicator, Biological Sterilization Process
Cleared on Sep 18, 2024 after a 495-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Sep 18, 2024
- Review
- 495 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 0
FDA’s file for it is a 510(k) statement, which names no predicate.
Sources: FDA 510(k) database (decision fields), the FDA 510(k) statement (indications), FDA recall and enforcement reports, and MAUDE; processed by 510(k) Report. Verify on FDA.gov · Methodology and accuracy.
Planning a device in FRC? 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 FRC device
- #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
- #2 Held for the reportin the report
- #3 Held for the reportin the report
What was it cleared against?
FDA’s file for it is a 510(k) statement, which names no predicate.
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.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2024, this device’s year, is highlighted.
FDA decisions per year · FRC
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · FRC
29in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · FRC
8so far in 2026, the most since 2007
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · FRC
9in 2025
MAUDE reports naming product code FRC, 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 | 3 | 83 | 0 | 100 |
| 2008 | 1 | — | 0 | 60 |
| 2009 | 6 | 183 | 1 | 45 |
| 2010 | 4 | 165 | 0 | 57 |
| 2011 | 6 | 118 | 0 | 37 |
| 2012 | 9 | 178 | 2 | 46 |
| 2013 | 4 | 260 | 2 | 39 |
| 2014 | 13 | 174 | 0 | 51 |
| 2015 | 3 | 130 | 0 | 182 |
| 2016 | 2 | — | 0 | 482 |
| 2017 | 10 | 130 | 0 | 182 |
| 2018 | 18 | 97 | 0 | 22 |
| 2019 | 5 | 88 | 0 | 30 |
| 2020 | 10 | 150 | 0 | 16 |
| 2021 | 5 | 107 | 0 | 10 |
| 2022 | 5 | 193 | 4 | 9 |
| 2023 | 6 | 190 | 1 | 20 |
| 2024 | 8 | 105 | 0 | 22 |
| 2025 | 6 | 29 | 0 | 9 |
| 2026 | 1 | — | 8 | — |
What is it indicated for?
Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems: • Sterrad® 100S Sterilization System. • Sterrad® l00NX Sterilization System (Standard and Express cycles). • V-Pro® maX Low Temperature Sterilization System (Non…
Read the full statement (266 words)
Terragene® Bionova® SCBI (BT95, BT96) is a self-contained biological indicator inoculated with a minimum of 10⁶ viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
• Sterrad® 100S Sterilization System.
• Sterrad® l00NX Sterilization System (Standard and Express cycles).
• V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• Sterizone® VP4 Sterilizer ( cycle 1 ).
• LowTem Crystal 120 Sterilizer (Standard cycle).
BT95 has rapid readout at 2 hours at 60 cc while BT96 has super rapid readout at 30 minutes at 60 cc.
Terragene® Chemdye® (CD42) is a chemical process indicator intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
• Sterrad® 100S Sterilization System.
• Sterrad® 100NX Sterilization System (Standard and Express cycles).
• V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• Sterizone® VP4 Sterilizer ( cycle 1 ).
• LowTem Crystal 120 Sterilizer (Standard cycle).
The chemical indicator changes from red to yellow to indicate that the conditions of the cycle have been met.
Terragene® Cintape® CT40 is a chemical process indicator tape intended for monitoring the efficacy of vaporized hydrogen peroxide sterilization processes in the following systems:
• Sterrad® 100S Sterilization System.
• Sterrad® 100NX Sterilization System (Standard and Express cycles).
• V-Pro® maX Low Temperature Sterilization System (Non Lumen, Lumen and Flexible cycles).
• Sterizone® VP4 Sterilizer ( cycle 1 ).
• LowTem Crystal 120 Sterilizer (Standard cycle).
The indicating tape changes from purple to green when exposure to vaporized hydrogen peroxide.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K231383 · printed Nov 5, 2026
Cite this page
510(k) Report. “K231383: Terragene® Bionova® Self-Contained Biological Indicator (BT95), Terragene® Bionova® Self-Contained Biological Indicator (BT96), Terragene® Chemdye® Chemical Process Indicator (CD42), Terragene® Cintape® Chemical Process Indicator Tape (CT40).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K231383
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Record history
- FDA decision record loaded May 2, 2026
- Summary read Oct 13, 2026 (extraction version 9eaa42aa01ed)
- Page last updated Nov 3, 2026