510(k) · Cleared
ClearedSTERIZONE VP4 Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Tso3 Inc., Now A Part of Stryker · FRC Indicator, Biological Sterilization Process
Cleared on Mar 24, 2021 as substantially equivalent to K141580 (Tso3, Inc., 2014) after a 107-day review. Its family tree reaches back 7 generations to 2002.
- Decided
- Mar 24, 2021
- Review
- 107 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 7 generations to K994055 (2002). 12 ancestors in all. No later device cites it as a predicate yet.
- Root · 7 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 6 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 5 generations backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- 4 generations backK102884 Sterrad Cyclesure 24 Biological IndicatorAdvanced Sterilization Products · 2011
- 3 generations backK111375 Sterrad (R) Cyclesure (R) 24 Biological IndicatorAdvanced Sterilization Products · 2012
- 2 generations backK123017 Sterrad Cyclesure 24 Biological Indicator Model 14324Advanced Sterilization Products · 2012
- 1 generation backK141580 Sterizone Self-Contained Biological IndicatorTso3, Inc. · 2014
- This deviceK203560 STERIZONE VP4 Test PackTso3 Inc., Now A Part of Stryker · 2021
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −7 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −6 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −5 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| −4 | K102884 | Sterrad Cyclesure 24 Biological Indicator | Advanced Sterilization Products | 2011 | — |
| −3 | K111375 | Sterrad (R) Cyclesure (R) 24 Biological Indicator | Advanced Sterilization Products | 2012 | — |
| −2 | K123017 | Sterrad Cyclesure 24 Biological Indicator Model 14324 | Advanced Sterilization Products | 2012 | — |
| −1 | K141580 | Sterizone Self-Contained Biological Indicator | Tso3, Inc. | 2014 | — |
| 0 (this device) | 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 |
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 |
|---|---|---|---|
| * | K141580 | Sterizone Self-Contained Biological IndicatorSummary page 5…) Summary 3. Legally Marketed Predicate Device Predicate Device STERIZONE® VP4 Test Pack K141580 Reference Device Terragene Bionova® SCBI (BT96) K191021 4.… | 2014 |
| † | K191021 | Terragene Bionova, Terragene Bionova, Terragene Integron, Terragene Cintape, Terragene… | 2019 |
What descends from it?
No later submission names this one as a predicate yet.
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 19 years and passes through 3 companies; a new generation was cleared every 2.0 years on median.
- 3 of the 12 ancestors have a recall of any class.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2021, 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@ VP4 Test Pack is intended to be used for routine monitoring of the STERIZONE@ VP4 Sterilizer cycle (Cycle 1) and for the performance validation of the STERIZONE@ VP4 Sterilizer system.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K203560 · printed Nov 5, 2026
Cite this page
510(k) Report. “K203560: STERIZONE VP4 Test Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K203560
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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