510(k) · Cleared
ClearedSterizone Self-Contained Biological Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tso3, Inc. · FRC Indicator, Biological Sterilization Process
Cleared on Dec 17, 2014 as substantially equivalent to K123017 (Advanced Sterilization Products, 2012) and 2 other predicates after a 187-day review. Its family tree reaches back 6 generations to 2002. 1 later device descends from it.
- Decided
- Dec 17, 2014
- Review
- 187 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 6 generations to K994055 (2002). 11 ancestors in all. 1 later device descends from it, 1 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 deviceK141580 Sterizone Self-Contained Biological IndicatorTso3, Inc. · 2014
- Descendant · cites it directly · 0 of its ownK203560 STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021
Most influential descendants
Showing 1 of 1 · See all- K203560STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021 · 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) | K141580 | Sterizone Self-Contained Biological Indicator | Tso3, Inc. | 2014 | — |
| +1 | K203560 | STERIZONE VP4 Test Pack | Tso3 Inc., Now A Part of Stryker | 2021 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2009 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2021 | 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? (3)
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…Hospital and Personal Use Devices Panel. Product code: FRC 5.3. Legally Marketed Equivalent Device Name(s) STERRAD® CYCLESURE® 24 Biological Indicator (K123017) STERRAD® 100NX DUO Cycle Test Pack (K111391) Verify® V24 Self-contained Biological Indicator (K090514)… | 2012 |
| * | K111391 | Sterrad (R) 100NX Duo Cycle Test PackSummary page 4…Product code: FRC 5.3. Legally Marketed Equivalent Device Name(s) STERRAD® CYCLESURE® 24 Biological Indicator (K123017) STERRAD® 100NX DUO Cycle Test Pack (K111391) Verify® V24 Self-contained Biological Indicator (K090514)… | 2012 |
| * | K090514 | Verify Self-Contained Biological Indicator for Vaporized (VH2O2) Sterilization ProcessesSummary page 4…ent Device Name(s) STERRAD® CYCLESURE® 24 Biological Indicator (K123017) STERRAD® 100NX DUO Cycle Test Pack (K111391) Verify® V24 Self-contained Biological Indicator (K090514) Page 5 - 1… | 2009 |
What descends from it? (1)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K203560 | STERIZONE VP4 Test Pack | 2021 | 0 |
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 12 years and passes through 2 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 11 ancestors have a recall of any class.
- Of its descendants, K203560 (Tso3 Inc., Now A Part of Stryker, 2021) has gone furthest, with 0 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. 2014, 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 STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle (“Cycle 17). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1. The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized hydrogen peroxide (H,0, or VHP) and ozone (O3) which are both used in the STERIZONE® VP4…
Read the full statement (329 words)
The STERIZONE® BI+ Self-contained Biological Indicator (SCBI) is intended for routine
monitoring of the STERIZONE® VP4 Sterilizer, which offers a single pre-set sterilization cycle
(“Cycle 17). The SCBI should only be used in a Test Pack configuration to monitor Cycle 1.
The SCBI placed within the STERIZONE® VP4 Test Pack monitors exposure to both vaporized
hydrogen peroxide (H,0, or VHP) and ozone (O3) which are both used in the STERIZONE®
VP4 Sterilizer. The STERIZONE® VP4 Test Pack is intended to have equivalent to greater
resistance than worst case devices and loads in any load configuration.
STERIZONE® VP4 Test Pack is a device composed of the STERIZONE® BI+ Self-contained
Biological Indicator (TSO; product code 42602, including crusher), a 10 mL syringe and its
plunger, and a diffusion restrictor (sold in the form of a kit - TSO3 product code: 44020). An
external STERIZONE® CI+ Chemical Indicator (TSO;3 product code 43810) is also added to
allow differentiating processed from unprocessed test packs. All components of the Test Pack
are single-use, disposable items.
The STERIZONE® VP4 Test Pack is constructed by first inserting the STERIZONE® BI+ Self-
contained Biological Indicator inside the syringe, with the SCBI cap facing to the Luer-lock of
the syringe. The plunger is then inserted to the 10 mL mark of the syringe. The diffusion
restrictor is screwed to the Luer-lock of the syringe. The chemical indicator is then inserted in
the opening between the plunger and the syringe.
The test pack is placed within the load on the upper shelf of the STERIZONE® VP4 Sterilizer
loading rack.
After processing, the SCBI is retrieved from the test pack. The SCBI is intended to provide
users with a means to assess spore kill by the STERIZONE® VP4 Sterilizer. A “no growth”
result from the SCBI after 18 hours of incubation indicates that the process achieved the
conditions necessary to kill at least 1 x 10 viable spores of Geobacillus stearothermophilus (6
logs) on the SCBI inoculated stainless steel carrier.
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/K141580 · printed Nov 6, 2026
Cite this page
510(k) Report. “K141580: Sterizone Self-Contained 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/K141580
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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