510(k) · Cleared
Recalled · Class II · 2025Terragene Bionova (R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova (R) IC10/20FR Reader Incubator
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 Nov 2, 2017 after a 314-day review. FDA’s file for it is a 510(k) statement, which names no predicate. 1 later device descends from it. It has been recalled 2 times.
- Decided
- Nov 2, 2017
- Review
- 314 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 2
- Predicates
- 0
1 later device descends from it, 1 citing it directly.
- This deviceK163646 Terragene Bionova (R) SCBI (BT220, BT221, BT222, BT223), Terragene…Terragene S.A. · 2017
- Descendant · cites it directly · 0 of its ownK251122 Terragene® Bionova® BT20 Biological IndicatorTerragene · 2025
Most influential descendants
Showing 1 of 1 · See all- K251122Terragene® Bionova® BT20 Biological IndicatorTerragene · 2025 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K163646 | Terragene Bionova (R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R)… | Terragene S.A. | 2017 | — |
| +1 | K251122 | Terragene® Bionova® BT20 Biological Indicator | Terragene | 2025 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2025 | 1 | 0 |
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? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K251122 | Terragene® Bionova® BT20 Biological Indicator | 2025 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jan 15, 2025 | Class II | Z-1248-2025 | Labeling False and Misleading | Error in the IFU lists an incorrect incubation time on one occasion of 20 minutes rather than the correct incubation time of 60 minutes. |
| Dec 7, 2023 | Class II | Z-0837-2024 | Labeling False and Misleading | Due to a discrepancy between the FDA-Cleared Indications for Use (IFU) and the actual IFU distributed with the products. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K251122 (Terragene, 2025) has gone furthest, with 0 descendants of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2017, 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 (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam. Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2) provides a defined…
Read the full statement (217 words)
Terragene Bionova® SCBI (BT220, BT221, BT222, BT223) is a self-contained biological indicator inoculated with viable 10° Geobacillus stearothermophilus bacterial spores and is intended for monitoring the efficacy of steam sterilization processes. On each Terragene Bionova® SCBI is a chemical process indicator that changes color from pink to brown when exposed to steam.
Terragene Bionova® PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2) provides a defined challenge resistance against the claimed cycles shown below and also demonstrated resistance equivalence to the AAMI/ANSI 16 towel pack. The device provides routine monitoring and sterilizer qualification testing steam sterilization processes.
Terragene Bionova® IC10/20FR Reader Incubator incubates at 60 ©C and reads the Terragene Bionova® SCBI (BT220, BT221, BT222, and BT223) for fluorescent results at 30 minutes (BT223), 1 hour (BT221, BT222), and 3 hours (BT220)
Models | 121°C | 1320C | 1359C
Gravity Displacement
BT220, BT222, PCD220-C, PCD220-2, PCD222-C, PCD222-2 | 30 minutes 15 minutes, 10 minutes 25 minutes
BT221, BT223 | NA | 130 minutes, 3 minutes, minutes 10 minutes
Dynamic Air Removal (Vacuum Assist)
BT220, BT222, PCD220-C, PCD220-2, PCD222-C, PCD222-2 | NA | 4 minutes 3 minutes
Models | Fluorescence Read Time | pH Color Change
BT221, BT222, PCD222-C, PCD222-2 | 1 hour | 48 Hours
BT223 | 30 minutes | 48 Hours
BT220, PCD220-C, PCD220-2 | 3 hours | 48 Hours
Indications for use read by OCR from a scanned FDA 510(k) statement, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K163646 · printed Nov 6, 2026
Cite this page
510(k) Report. “K163646: Terragene Bionova (R) SCBI (BT220, BT221, BT222, BT223), Terragene Bionova (R) PCD (PCD220-C, PCD220-2, PCD222-C, PCD222-2), and Terragene Bionova (R) IC10/20FR Reader Incubator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K163646
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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