510(k) · Cleared
ClearedSTERRAD CYCLESURE 24 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 Oct 29, 2015 as substantially equivalent to K123017 (Advanced Sterilization Products, 2012) after a 105-day review. Its family tree reaches back 6 generations to 2002. 5 later devices descend from it.
- Decided
- Oct 29, 2015
- Review
- 105 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 6 generations to K994055 (2002). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 6 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 5 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 4 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- 3 generations backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- 2 generations backK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
- 1 generation backK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
- This deviceK151971 STERRAD CYCLESURE 24 Biological IndicatorAdvanced Sterilization Products · 2015
- Descendant · cites it directly · 3 of its ownK170039 STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017
- Descendant · 2 generations on · 2 of its ownK182404 STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018
- Descendant · 3 generations on · 1 of its ownK192025 STERRAD VELOCITY Biological Indicator/Process Challenge Device and…Advanced Sterilization Products (Asp) · 2020
- Descendant · 4 generations on · 0 of its ownK234084 STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE®…Advanced Sterilization Products, Inc. · 2024
- Descendant · cites it directly · 0 of its ownK171287 Sporview VH202 BISpsmedical Supply Corp. A Division of Cantel Medical · 2018
Most influential descendants
Showing 5 of 5 · See all- K170039STERRAD VELOCITY Biological Indictator and ReaderAdvanced Sterilization Products (Asp) · 2017 · cites it directly3descendants
- K182404STERRAD VELOCITY Biological IndicatorAdvanced Sterilization Products (Asp) · 2018 · 2 generations on2descendants
- K192025STERRAD VELOCITY Biological Indicator/Process Challenge Device and ReaderAdvanced Sterilization Products (Asp) · 2020 · 3 generations on1descendant
- K234084STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical Indicator…Advanced Sterilization Products, Inc. · 2024 · 4 generations on0descendants
- K171287Sporview VH202 BISpsmedical Supply Corp. A Division of Cantel Medical · 2018 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −6 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −5 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −4 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| −3 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| −2 | K111375 | Sterrad (R) Cyclesure (R) 24 Biological Indicator | Advanced Sterilization Products | 2012 | — |
| −1 | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324 | Advanced Sterilization Products | 2012 | — |
| 0 (this device) | K151971 | STERRAD CYCLESURE 24 Biological Indicator | Advanced Sterilization Products | 2015 | — |
| +1 | K170039 | STERRAD VELOCITY Biological Indictator and Reader | Advanced Sterilization Products (Asp) | 2017 | — |
| +2 | K182404 | STERRAD VELOCITY Biological Indicator | Advanced Sterilization Products (Asp) | 2018 | — |
| +3 | K192025 | STERRAD VELOCITY Biological Indicator/Process Challenge Device and Reader | Advanced Sterilization Products (Asp) | 2020 | — |
| +4 | K234084 | STERRAD™ Chemical Indicator (CI) Strip (14100); STERRAD® SEALSURE® Chemical… | Advanced Sterilization Products, Inc. | 2024 | — |
| +1 | K171287 | Sporview VH202 BI | Spsmedical Supply Corp. A Division of Cantel Medical | 2018 | — |
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 |
|---|---|---|
| 2017 | 1 | 0 |
| 2018 | 2 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324Summary page 4…Biological Sterilization Process Indicator (21 CFR 880.2800) Regulatory Class: II Product Code: FRC III. PREDICATE DEVICE STERRAD CYCLESURE 24 Biological Indicator K123017 No reference devices were used in this submission. IV. DEVICE DESCRIPTION The STERRAD CYCLESURE 24 Biological Indicator (… | 2012 |
What descends from it? (5)
2 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 13 years and passes through 1 company; a new generation was cleared every 2.8 years on median.
- 3 of the 7 ancestors have a recall of any class.
- Of its descendants, K170039 (Advanced Sterilization Products (Asp), 2017) has gone furthest, with 3 descendants of its own.
- 2 other devices also cite its predicate K123017.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2015, 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 has been validated for use in health care facilities:
• STERRAD 100S
• STERRAD 50
• STERRAD 200
• STERRAD NX®
• STERRAD 100NX® (Standard, Flex and Express Cycles)
o For STERRAD 100NX DUO Cycle in the United States, 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/K151971 · printed Nov 6, 2026
Cite this page
510(k) Report. “K151971: STERRAD CYCLESURE 24 Biological Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K151971
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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