510(k) · Cleared
Recalled · Class II · 2026Verify Scbi 275F 3-10
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FRC Indicator, Biological Sterilization Process
Cleared on Sep 1, 2009 as substantially equivalent to K051056 (Albert Browne, Ltd., 2005) and 2 other predicates after a 265-day review. Its family tree reaches back 2 generations to 1980. It has been recalled 7 times.
- Decided
- Sep 1, 2009
- Review
- 265 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 7
- Predicates
- 3
Its longest line of descent runs back 2 generations to K801109 (1980). 6 ancestors in all. No later device cites it as a predicate yet.
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K801109 | Proof (Biological/Chemical Indicator) | Amsco Co. | 1980 | — |
| −1 | K963841 | Eztest | Sgm Biotech, Inc. | 1997 | 1 |
| 0 (this device) | K083665 | Verify Scbi 275F 3-10 | STERIS Corporation | 2009 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1986 | 1 | 0 |
| 1990 | 1 | 0 |
| 1994 | 1 | 0 |
| 2005 | 1 | 0 |
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 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? (3)
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 |
|---|---|---|---|
| * | K051056 | Verify Self-Contained Biological IndicatorSummary page 2…Biological Sterilization Process Indicators (21 CFR 880.2800), Product Code FRC 2. Predicate Device · K051056, Verify® Dual Series SCBI cleared as Verify® Self-Contained Biological Indicator · K855101, Verify® Dua… | 2005 |
| * | K855101 | Assert TM Biological/Chemical IndicatorSummary page 2…uct Code FRC 2. Predicate Device · K051056, Verify® Dual Series SCBI cleared as Verify® Self-Contained Biological Indicator · K855101, Verify® Dual Series SCBI cleared as Verify® Self-Contained Biological Indicator cleared as AssertTM Biological/Che… | 1986 |
| * | K963841 | EztestSummary page 2…K855101, Verify® Dual Series SCBI cleared as Verify® Self-Contained Biological Indicator cleared as AssertTM Biological/Chemical Indicator · K963841, SGM EZTest Steam BI 3. Description of Device The proposed Verify® SCBI 275F 3-10 is a self-contained biological indi… | 1997 |
What descends from it?
No later submission names this one as a predicate yet.
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Aug 31, 2026 | Class II | Z-0073-2027 | Under Investigation by firm | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no… |
| Aug 31, 2026 | Class II | Z-0072-2027 | Under Investigation by firm | Geobacillus stearothermophilus spore population in affected products may fall below minimum shelf life specification. When used to monitor steam sterilization cycles, the potential hazard is that the biological indicator will show no… |
| Dec 12, 2022 | Class II | Z-0778-2023 | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to… |
| Dec 12, 2022 | Class II | Z-0779-2023 | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to… |
| Dec 12, 2022 | Class II | Z-0780-2023 | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to… |
| Dec 12, 2022 | Class II | Z-0781-2023 | Employee error | Biological indicator (BI) used to promote growth of the G. stearothermophilus and B. atrophaeus spores was inconsistent in promoting growth throughout lot , some BIs within the lot performed as intended while others did not. When used to… |
| Sep 10, 2013 | Class II | Z-0605-2014 | Use error | STERIS has identified that the population of the G. stearothermophilus spores that monitor STEAM sterilization cycles does not meet specifications for Lot # 131004 of the Verify Dual Species Self-Contained Biological Indicators. As a… |
The 5 latest of 7 recalls; the web page lists all.
No ancestor or descendant has a Class I recall.
What does this lineage say?
- The line of descent spans 29 years and passes through 3 companies; a new generation was cleared every 16.7 years on median.
- 2 of the 6 ancestors have a recall of any class.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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?
The Verify® SCBI 275F 3-10 is a self-contained biological indicator that may be used for installation testing and routine monitoring of steam sterilizers. The Verify® SCBI 275F 3-10 provides independent confirmation that sterilization conditions were achieved during the following cycles:
275°F (135 0C) Gravity Flash 3 minutes
275°F (135 0C) Prevacuum 3 minutes
275°F (135 0C) Gravity 10 minute
275°F (135°C) Gravity Flash 10 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K083665 · printed Nov 4, 2026
Cite this page
510(k) Report. “K083665: Verify Scbi 275F 3-10.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K083665
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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