510(k) · Cleared
ClearedSterrad Cyclesure 24 Biological Indicator Model 14324
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 Dec 26, 2012 as substantially equivalent to K111375 (Advanced Sterilization Products, 2012) after an 89-day review. Its family tree reaches back 5 generations to 2002. 17 later devices descend from it.
- Decided
- Dec 26, 2012
- Review
- 89 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K994055 (2002). 6 ancestors in all. 17 later devices descend from it, 3 citing it directly.
- Root · 5 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 4 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 3 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- 2 generations backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- 1 generation backK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
- This deviceK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
- Descendant · cites it directly · 12 of its ownK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
- Descendant · 2 generations on · 11 of its ownK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
- Descendant · 3 generations on · 6 of its ownK160546 3M Attest Rapid Readout Biological Indicator3M Company · 2016
- Descendant · 2 generations on · 5 of its ownK171003 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company · 2017
- Descendant · cites it directly · 5 of its ownK151971 STERRAD CYCLESURE 24 Biological IndicatorAdvanced Sterilization Products · 2015
Showing 5 of 17 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 17 · See all- K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014 · cites it directly12descendants
- K1520603M Attest Rapid Readout Biological Indicator 12953M Company · 2015 · 2 generations on11descendants
- K1605463M Attest Rapid Readout Biological Indicator3M Company · 2016 · 3 generations on6descendants
- K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company · 2017 · 2 generations on5descendants
- K151971STERRAD CYCLESURE 24 Biological IndicatorAdvanced Sterilization Products · 2015 · cites it directly5descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −4 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −3 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| −2 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| −1 | K111375 | Sterrad (R) Cyclesure (R) 24 Biological Indicator | Advanced Sterilization Products | 2012 | — |
| 0 (this device) | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324 | Advanced Sterilization Products | 2012 | — |
| +1 | K140392 | 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader | 3M Company | 2014 | — |
| +2 | K152060 | 3M Attest Rapid Readout Biological Indicator 1295 | 3M Company | 2015 | — |
| +3 | K160546 | 3M Attest Rapid Readout Biological Indicator | 3M Company | 2016 | — |
| +2 | K171003 | 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader | 3M Company | 2017 | — |
| +1 | K151971 | STERRAD CYCLESURE 24 Biological Indicator | Advanced Sterilization Products | 2015 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2014 | 2 | 0 |
| 2015 | 2 | 0 |
| 2016 | 1 | 0 |
| 2017 | 2 | 0 |
| 2018 | 3 | 0 |
| 2020 | 2 | 0 |
| 2021 | 2 | 0 |
| 2022 | 1 | 0 |
| 2024 | 2 | 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? (1)
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 |
|---|---|---|---|
| * | K111375 | Sterrad (R) Cyclesure (R) 24 Biological IndicatorSummary page 1…tion: 21 CFR 880.2800 Proprietary Name: STERRAD®'CYCLESURE® 24 Biological Indicator 2. PREDICATE DEVICES STERRAD® CYCLESURE® 24 Biological Indicator, K1 11375, 9/14/20 12 3. INDICATIONS FOR USE The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard met… | 2012 |
What descends from it? (17)
See all 173 later devices cite it directly; ranked here by how many devices descend from each in turn.
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.
What does this lineage say?
- The line of descent spans 10 years and passes through 1 company; a new generation was cleared every 1.6 years on median.
- 3 of the 6 ancestors have a recall of any class.
- Of its descendants, K140392 (3M Company, 2014) has gone furthest, with 12 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. 2012, 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 STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a standard method for frequent monitoring of the following STERRAD® Sterilization Systems and Cycles:
* STERRAD® 100S
* STERRAD® 50
* STERRAD® 200
* STERRAD® NX
* STERRAD® 100NX® (Standard, Flex and Express Cycles)
For STERRAD® 100NX® DUO Cycle, the STERRAD® CYCLESURE® 24 Biological Indicator should only be used in a test pack configuration (REF 20243).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K123017 · printed Nov 6, 2026
Cite this page
510(k) Report. “K123017: Sterrad Cyclesure 24 Biological Indicator Model 14324.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K123017
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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