510(k) · Cleared

Recalled · 2009

Sterrad Cyclesure Biological Indicator

K031226510(k) SpecialCleared May 2, 200314-day reviewClass II21 CFR 880.2800Recalls 1

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 May 2, 2003 as substantially equivalent to K994055 (Advanced Sterilization Products, 2002) after a 14-day review. Its family tree reaches back 1 generation to 2002. 43 later devices descend from it. It has been recalled once.

Decided: May 2, 2003
Review: 14 days
Class: Class II
Product code: FRC
Recalls: 1
Predicates: 1

Its longest line of descent runs back 1 generation to K994055 (2002). 43 later devices descend from it, 3 citing it directly.

By dateBy generation

Root · 1 generation backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
This deviceK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003
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
Descendant · 3 generations on · 18 of its ownK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012

Showing 5 of 43 descendants. See all descendants

Descendants cleared per year

2007high 7 (2018) · low 0 (2010)2026

Most influential descendants

Showing 5 of 43 · See all

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
K111375Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012 · 3 generations on18descendants

View FIG. 1 as a table

Line of descent and top descendants

Generation	Number	Device	Applicant	Decided	Recalls
−1	K994055	Sterrad Cyclesure Biological Indicator	Advanced Sterilization Products	2002	1
0 (this device)	K031226	Sterrad Cyclesure Biological Indicator	Advanced Sterilization Products	2003	—
+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	—
+3	K111375	Sterrad (R) Cyclesure (R) 24 Biological Indicator	Advanced Sterilization Products	2012	—

Descendants by year cleared

Year cleared	Devices	With a Class I recall
2007	1	0
2008	1	0
2009	1	0
2011	2	0
2012	3	0
2014	5	0
2015	2	0
2016	1	0
2017	4	0
2018	7	0
2019	2	0
2020	2	0
2021	2	0
2022	2	0
2023	2	0
2024	2	0
2025	3	0
2026	1	0

FIG. 1 — Lineage of K031226, 2002–2026Source: FDA 510(k) summaries, read by 510(k) Report · How lineage is built

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
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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	Applicant	Decided	Recalls
*	K994055	Sterrad Cyclesure Biological Indicator Summary page 1 …cal Indicator Common Name Biological Indicator Classification Name Class I1 Legally Marketed Equivalent Device Name(s) STERRADO CycleSureTMBiological Indicator, K994055, February 13,2002. DIVISION OF ETHICON, INC. e 33 TECHNOLOGY DRIVE 0 IRVINE, CA 92618 0 (949)581-5799 FAX (949)789-3900…	Advanced Sterilization Products	2002	1

Also cleared against K994055: 4 other devices →

What descends from it? (43)

See all 43

3 later devices cite it directly; ranked here by how many devices descend from each in turn.

Number	Device	Applicant	Decided	Descendants
K071014	Modification to Sterrad Cyclesure Biological Indicator	Advanced Sterilization Products	2007	42
K073244	Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes	STERIS Corporation	2008	20
K090514	Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization Processes	STERIS Corporation	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?

Its one ancestor has a recall.
Of its descendants, K071014 (Advanced Sterilization Products, 2007) has gone furthest, with 42 descendants of its own.
4 other devices also cite its predicate K994055.

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.

FDA decisions per year · FRC

6in 2025

2007high 18 (2018) · low 1 (2008)2026

2026 to Oct 25, outlined.

Median 510(k) review, days · FRC

29in 2025

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

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

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

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@CycleSureTMBiological Indicator is intended to be used as a standard method for frequent monitoring of the STERRAD@Sterilizer cycles.

Indications for use as stated in the FDA summary.

https://510kreport.com/device/K031226 · printed Nov 6, 2026

Cite this page

510(k) Report. “K031226: Sterrad Cyclesure 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/K031226

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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