510(k) · Cleared
Recalled · 2009Sterrad Cyclesure Biological Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Advanced Sterilization Products · FRC Indicator, Biological Sterilization Process
Cleared on Feb 13, 2002 after an 806-day review. The FDA summary names its predicate without a number. 55 later devices descend from it. It has been recalled once.
- Decided
- Feb 13, 2002
- Review
- 806 days
- Class
- Class II
- Product code
- FRC
- Recalls
- 1
- Predicates
- 0
55 later devices descend from it, 5 citing it directly.
- This deviceK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002
- Descendant · cites it directly · 43 of its ownK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- Descendant · cites it directly · 42 of its ownK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- Descendant · 2 generations on · 20 of its ownK103222 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2011 · Recalled
- Descendant · 2 generations on · 20 of its ownK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- Descendant · cites it directly · 20 of its ownK073244 Verify Self-Contained Biological Indicator for VH202 Gaseous…STERIS Corporation · 2008
Showing 5 of 55 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 55 · See all- K031226Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · cites it directly43descendants
- K071014Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007 · cites it directly42descendants
- K103222Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2011 · 2 generations on20descendants
- K102884Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011 · 2 generations on20descendants
- K073244Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization ProcessesSTERIS Corporation · 2008 · cites it directly20descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | — |
| +1 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| +1 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| +2 | K103222 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2011 | 4 |
| +2 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| +1 | K073244 | Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization… | STERIS Corporation | 2008 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2003 | 1 | 0 |
| 2007 | 2 | 0 |
| 2008 | 1 | 0 |
| 2009 | 2 | 0 |
| 2011 | 2 | 0 |
| 2012 | 3 | 0 |
| 2014 | 7 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 4 | 0 |
| 2018 | 8 | 0 |
| 2019 | 4 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 2 | 0 |
| 2023 | 4 | 0 |
| 2024 | 4 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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? (2)
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 |
|---|---|---|---|
| * | — | 3M™ Attest™ Biological Indicator Named without a submission number | |
| * | — | STERRAD® BI Test Pack Named without a submission number |
What descends from it? (55)
See all 555 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K031226 | Sterrad Cyclesure Biological Indicator | 2003 | 43 |
| K071014 | Modification to Sterrad Cyclesure Biological Indicator | 2007 | 42 |
| K073244 | Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes | 2008 | 20 |
| K072510 | Verify V-Pro Chemical Indicator, Versions 1 and 2 | 2007 | 10 |
| K090514 | Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization Processes | 2009 | 4 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Jun 23, 2009 | Not classified | Z-0066-2010 | Device Design | Biological Indicator indicating a positive result does not maintain yellow color for the entire incubation period and some indicators experience media evaporation prior to the end of the labeled maximum incubation time. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K031226 (Advanced Sterilization Products, 2003) has gone furthest, with 43 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.
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 STERRAD® CycleSureTM Biological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD® Sterilizer cycles.
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/K994055 · printed Nov 5, 2026
Cite this page
510(k) Report. “K994055: Sterrad Cyclesure Biological Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K994055
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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