510(k) · Cleared
ClearedVerify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · FRC Indicator, Biological Sterilization Process
Cleared on May 28, 2008 as substantially equivalent to K994055 (Advanced Sterilization Products, 2002) and 2 other predicates after a 191-day review. Its family tree reaches back 3 generations to 2002. 20 later devices descend from it.
- Decided
- May 28, 2008
- Review
- 191 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 3 generations to K994055 (2002). 20 later devices descend from it, 3 citing it directly.
- Root · 3 generations backK994055 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2002 · Recalled
- 2 generations backK031226 Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2003 · Recalled
- 1 generation backK071014 Modification to Sterrad Cyclesure Biological IndicatorAdvanced Sterilization Products · 2007
- This deviceK073244 Verify Self-Contained Biological Indicator for VH202 Gaseous…STERIS Corporation · 2008
- Descendant · cites it directly · 14 of its ownK140499 Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation · 2014
- Descendant · 2 generations on · 9 of its ownK171504 VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · Recalled
- Descendant · 2 generations on · 8 of its ownK173488 CELERITY 20 HP Challenge PackSTERIS Corporation · 2018
- Descendant · 3 generations on · 8 of its ownK172752 CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018
- Descendant · 3 generations on · 6 of its ownK183294 CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation · 2019
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2014 · cites it directly14descendants
- K171504VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · 2 generations on9descendants
- K173488CELERITY 20 HP Challenge PackSTERIS Corporation · 2018 · 2 generations on8descendants
- K172752CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018 · 3 generations on8descendants
- K183294CELERITY 20 HP Biological Indicator, CELERITY HP Challenge PackSTERIS Corporation · 2019 · 3 generations on6descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K994055 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2002 | 1 |
| −2 | K031226 | Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2003 | 1 |
| −1 | K071014 | Modification to Sterrad Cyclesure Biological Indicator | Advanced Sterilization Products | 2007 | — |
| 0 (this device) | K073244 | Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization… | STERIS Corporation | 2008 | — |
| +1 | K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202… | STERIS Corporation | 2014 | — |
| +2 | K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | 1 |
| +2 | K173488 | CELERITY 20 HP Challenge Pack | STERIS Corporation | 2018 | — |
| +3 | K172752 | CELERITY 20 HP Biological Indicator | STERIS Corporation | 2018 | — |
| +3 | K183294 | CELERITY 20 HP Biological Indicator, CELERITY HP Challenge Pack | STERIS Corporation | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2009 | 1 | 0 |
| 2014 | 3 | 0 |
| 2017 | 2 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 0 |
| 2021 | 1 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2025 | 3 | 0 |
| 2026 | 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 |
|---|---|---|---|
| * | K994055 | Sterrad Cyclesure Biological IndicatorSummary page 2…or, Biological Sterilization Process (21 CFR 880.2800, FRC). 2. Predicate Device STERRAD® CyclesureTM Biological Indicator, K994055, Feb 13, 2002 STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 STERRAD® Cyclesure Biological Indicator, K0… | 2002 |
| * | K031226 | Sterrad Cyclesure Biological IndicatorSummary page 2…(21 CFR 880.2800, FRC). 2. Predicate Device STERRAD® CyclesureTM Biological Indicator, K994055, Feb 13, 2002 STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 STERRAD® Cyclesure Biological Indicator, K071014 May 24, 2007 3. Description of Device The Verify Sel… | 2003 |
| * | K071014 | Modification to Sterrad Cyclesure Biological IndicatorSummary page 2…CyclesureTM Biological Indicator, K994055, Feb 13, 2002 STERRAD® Cyclesure Biological Indicator, K031226, May 2, 2003 STERRAD® Cyclesure Biological Indicator, K071014 May 24, 2007 3. Description of Device The Verify Self-Contained Biological Indicator (SCBI) for Vaporized Steriliz… | 2007 |
What descends from it? (20)
See all 203 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 6 years and passes through 2 companies; a new generation was cleared every 1.2 years on median.
- 2 of the 3 ancestors have a recall of any class.
- Of its descendants, K140499 (STERIS Corporation, 2014) has gone furthest, with 14 descendants of its own.
- 4 other devices also cite its predicate K994055.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2008, 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 Verify Self-Contained Biological Indicator for Vaporized H₂O Sterilization Processes is intended as a standard method for frequent monitoring of the Amsco® V-PRO™ 1 Low Temperature Sterilization System.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073244 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073244: Verify Self-Contained Biological Indicator for VH202 Gaseous Sterilization Processes.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073244
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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