510(k) · Cleared
ClearedTerragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB)
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 Feb 28, 2023 after a 267-day review. FDA’s file for it is a 510(k) statement, which names no predicate.
- Decided
- Feb 28, 2023
- Review
- 267 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. 2023, 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® Hyper Biological Indicator (BT98) is a self-contained biological indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of Plasma or Vaporized Hydrogen Peroxide sterilization processes in the following systems: -Sterrad® 100S Sterilization System. -Sterrad® NX Sterilization System (Standard and Advanced Cycles). -Sterrad® NX with ALLClear®…
Read the full statement (178 words)
Terragene® Bionova® Hyper Biological Indicator (BT98) is a self-contained biological indicator (SCBI) inoculated with a minimum of 106 viable Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of Plasma or Vaporized Hydrogen Peroxide sterilization processes in the following systems:
-Sterrad® 100S Sterilization System.
-Sterrad® NX Sterilization System (Standard and Advanced Cycles).
-Sterrad® NX with ALLClear® Technology Sterilization System (Standard and Advanced Cycles).
-Sterrad® l00NX Sterilization System (Standard, Flex, Express and Duo Cycles).
-Sterrad® lO0NX with ALLClear® Technology Sterilization System (Standard, Flex, Express and Duo Cycles).
-V-Pro® S2 Low Temperature Sterilization System (Fast, Non Lumen, Lumen and Flexible Cycles).
-V-Pro® maX 2 Low Temperature Sterilization System (Fast Non Lumen, Non Lumen, Lumen and Flexible Cycles).
Terragene® Bionova® BT98 has Hyper Rapid readout at 5 minutes at 60 °C.
Terragene® Bionova® Hyper Auto-reader Incubator (BHY) incubates at 60 °C and reads the Terragene® Bionova® Hyper SCBis at the times prescribed in the User Manual.
Terragene® Bionova® NanoBio Auto-reader Incubator (BNB) incubates at 60 °C and reads the Bionova® SCBis at the times prescribed in the User Manual.
Indications for use as stated in the FDA 510(k) statement.
https://510kreport.com/device/K221641 · printed Nov 4, 2026
Cite this page
510(k) Report. “K221641: Terragene® Bionova® Hyper Biological Indicator (BT98), Terragene® Bionova® Hyper Auto-reader Incubator (BHY), Terragene® Bionova® NanoBio Auto-reader Incubator (BNB).” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K221641
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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