510(k) Report

510(k) · Cleared

Cleared

Sterrad (R) Cyclesure (R) 24 Biological Indicator

K111375510(k) TraditionalCleared Sep 14, 2012487-day reviewClass II21 CFR 880.2800

Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly, last Nov 3, 2026

Advanced Sterilization Products · FRC Indicator, Biological Sterilization Process

Cleared on Sep 14, 2012 as substantially equivalent to K102884 (Advanced Sterilization Products, 2011) and 1 other predicate after a 487-day review. Its family tree reaches back 4 generations to 2002. 18 later devices descend from it.

Decided
Sep 14, 2012
Review
487 days
Class
Class II
Product code
FRC
Recalls
None
Predicates
2

Its longest line of descent runs back 4 generations to K994055 (2002). 5 ancestors in all. 18 later devices descend from it, 1 citing it directly.

Other ancestors, by year clearedDescendants, by year cleared 2011: 1 other ancestor2012: 1 descendant cleared2014: 2 descendants cleared2015: 2 descendants cleared2017: 2 descendants cleared2021: 2 descendants cleared2018: 3 descendants cleared2016: 1 descendant cleared2020: 2 descendants cleared2024: 2 descendants cleared2022: 1 descendant clearedK994055 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2002 · recalledK031226 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2003 · recalledK071014 · Modification to Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2007K102884 · Sterrad Cyclesure 24 Biological Indicator · Advanced Sterilization Products · 2011200020052010201520202025
Other ancestors, by generationDescendants, by generation 1 generation back: 1 other ancestor 1 generation forward: 1 descendant2 generations forward: 3 descendants3 generations forward: 5 descendants4 generations forward: 3 descendants5 generations forward: 2 descendants6 generations forward: 2 descendants7 generations forward: 1 descendant8 generations forward: 1 descendant K102884 · Sterrad Cyclesure 24 Biological Indicator · Advanced Sterilization Products · 2011K071014 · Modification to Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2007K031226 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2003 · recalledK994055 · Sterrad Cyclesure Biological Indicator · Advanced Sterilization Products · 2002 · recalled0+5
  1. Root · 4 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
  2. 3 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
  3. 2 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
  4. 1 generation backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
  5. This deviceK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
  6. Descendant · cites it directly · 17 of its ownK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
  7. Descendant · 2 generations on · 12 of its ownK140392 3M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014
  8. Descendant · 3 generations on · 11 of its ownK152060 3M Attest Rapid Readout Biological Indicator 12953M Company · 2015
  9. Descendant · 4 generations on · 6 of its ownK160546 3M Attest Rapid Readout Biological Indicator3M Company · 2016
  10. Descendant · 3 generations on · 5 of its ownK171003 3M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company · 2017

Showing 5 of 18 descendants. See all descendants

Descendants cleared per year

2012: 12014: 22015: 22016: 12017: 22018: 32020: 22021: 22022: 12024: 2
2012high 3 (2018) · low 0 (2013)2026

Most influential descendants

Showing 5 of 18 · See all
  • K123017Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012 · cites it directly17descendants
  • K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company · 2014 · 2 generations on12descendants
  • K1520603M Attest Rapid Readout Biological Indicator 12953M Company · 2015 · 3 generations on11descendants
  • K1605463M Attest Rapid Readout Biological Indicator3M Company · 2016 · 4 generations on6descendants
  • K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company · 2017 · 3 generations on5descendants
View FIG. 1 as a table

Line of descent and top descendants

GenerationNumberDeviceApplicantDecidedRecalls
−4K994055Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products20021
−3K031226Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products20031
−2K071014Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products2007—
−1K102884Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products2011—
0 (this device)K111375Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products2012—
+1K123017Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products2012—
+2K1403923M Attest Rapid Readout Biological Indicator / 3M Attest Auto-Reader3M Company2014—
+3K1520603M Attest Rapid Readout Biological Indicator 12953M Company2015—
+4K1605463M Attest Rapid Readout Biological Indicator3M Company2016—
+3K1710033M Attest Rapid Readout Biological Indicator, 3M Attest Auto-reader3M Company2017—

Other ancestors by year cleared

Year clearedDevicesWith a Class I recall
201110

Descendants by year cleared

Year clearedDevicesWith a Class I recall
201210
201420
201520
201610
201720
201830
202020
202120
202210
202420
FIG. 1 — Lineage of K111375, 2002–2024Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

Get the monthly Device Review Tracker

Notable FDA decisions, review times and new Class I recalls. See an issue.

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. #1 K250044 Celerity 5 HP Biological Indicator (LCB052)…score 14.5 · 10 generations · no Class I recall
  2. #2 Held for the reportin the report
  3. #3 Held for the reportin the report
Get a 510(k) 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.

TypeNumberDeviceApplicantDecidedRecalls
*K102884Sterrad Cyclesure 24 Biological Indicator
Summary page 1
…21 CFR 880.2200 Proprietary Name: STERRAD® CYCLESURE® 24 Biological indicator 2. PREDICATE DEVICES * STERRAD® CYCLESURE® 24 Biological Indicator, K 102884, 1/28/2011 0 STERRAD® CYCLESURE® 24 Biological Indicator for use in STERRAD® EXPRESS Cycle, K103222, 2/25/2011 =…
Advanced Sterilization Products2011—
*K103222Sterrad Cyclesure Biological Indicator
Summary page 1
…* STERRAD® CYCLESURE® 24 Biological Indicator, K 102884, 1/28/2011 0 STERRAD® CYCLESURE® 24 Biological Indicator for use in STERRAD® EXPRESS Cycle, K103222, 2/25/2011 3. INDICATIONS FOR USE The STERRAD® CYCLESURE® 24 Biological Indicator is intended to be used as a…
Advanced Sterilization Products20114

Also cleared against K102884: 1 other device →

What descends from it? (18)

See all 18

1 later device cites it directly; ranked here by how many devices descend from each in turn.

NumberDeviceApplicantDecidedDescendants
K123017Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products201217

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 3.7 years on median.
  • 3 of the 5 ancestors have a recall of any class.
  • Of its descendants, K123017 (Advanced Sterilization Products, 2012) has gone furthest, with 17 descendants of its own.
  • 1 other device also cites its predicate K102884.

How does its category compare?

All FRC devices

FRC 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

2007: 32008: 12009: 62010: 42011: 62012: 92013: 42014: 132015: 32016: 22017: 102018: 182019: 52020: 102021: 52022: 52023: 62024: 82025: 62026 (partial year): 1
2007high 18 (2018) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRC

29in 2025

2007: 83 days median2009: 183 days median2010: 165 days median2011: 118 days median2012: 178 days median2013: 260 days median2014: 174 days median2015: 130 days median2017: 130 days median2018: 97 days median2019: 88 days median2020: 150 days median2021: 107 days median2022: 193 days median2023: 190 days median2024: 105 days median2025: 29 days median
2007high 260 (2013) · low 29 (2025)2026

Receipt to decision; years with fewer than 3 clearances left blank.

Recalls per year · FRC

8so far in 2026, the most since 2007

2009: 12012: 22013: 22022: 42023: 12026 (partial year): 8
2007high 8 (2026) · low 0 (2007)2026

Class I (0 since 2007) Class II/III not classified

Adverse event reports per year · FRC

9in 2025

2007: 1002008: 602009: 452010: 572011: 372012: 462013: 392014: 512015: 1822016: 4822017: 1822018: 222019: 302020: 162021: 102022: 92023: 202024: 222025: 9
2007high 482 (2016) · low 9 (2022)2025

MAUDE reports naming product code FRC, not matched to any one device; reports are not rates.

View these four charts as a table
YearDecisionsMedian 510(k) review, daysRecalls (Class I)MAUDE reports
20073830100
20081—060
20096183145
20104165057
20116118037
20129178246
20134260239
201413174051
201531300182
20162—0482
2017101300182
20181897022
2019588030
202010150016
20215107010
2022519349
20236190120
20248105022
202562909
20261—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® 1005S

* STERRAD® 50

* STERRAD® 200

* STERRAD® NX®

* STERRAD® 100NX® (Standard, Flex and Express Cycles)

o 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.

Also cleared against K102884

1 other device cites the same predicate.

  • K141238Sterilucent Self-Contained Biological IndicatorSterilucent, Inc. · 2014

More from Advanced Sterilization Products

54 FDA decisions under this applicant name. See the company

  • K234082STERRAD® 100NX Sterilizer with ALLClear™ Technology and ULTRA GI™ Cycle (10104); APTIMAX™ Instrument Tray…Advanced Sterilization Products · 2024
  • K163598Tyvek Self-Seal Pouches with STERRAD Chemical Indicator, Tyvek Rolls with STERRAD Chemical Indicator, Tyvek…Advanced Sterilization Products · 2017
  • K162007STERRAD NX SterilizerAdvanced Sterilization Products · 2017
  • K160818STERRAD® NX Sterilizer with ALLClear™ TechnologyAdvanced Sterilization Products · 2016
  • K160903STERRAD 100NX Sterilizer with ALLClearTM TechnologyAdvanced Sterilization Products · 2016

Recent decisions in FRC

The FRC category page

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  • K251452Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…Steris · 2025
  • K250044Celerity 5 HP Biological Indicator (LCB052); Celerity 5 HP Challenge Pack (LCB059); Celerity 20 HP…STERIS Corporation · 2025

https://510kreport.com/device/K111375 · printed Nov 6, 2026

Cite this page

510(k) Report. “K111375: Sterrad (R) Cyclesure (R) 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/K111375

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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