510(k) · Cleared
ClearedVerify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization
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 Dec 30, 2009 as substantially equivalent to K073618 (STERIS Corporation, 2009) after a 100-day review. Its family tree reaches back 3 generations to 2005. 20 later devices descend from it.
- Decided
- Dec 30, 2009
- Review
- 100 days
- Class
- Class II
- Product code
- FRC
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K042450 (2005). 20 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 2 generations backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
- 1 generation backK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
- This deviceK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
- Descendant · cites it directly · 15 of its ownK103331 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2011
- Descendant · 2 generations on · 14 of its ownK140499 Verify V24 Self-Contained Biological Indicator for Vaporized VH202…STERIS Corporation · 2014
- Descendant · 3 generations on · 9 of its ownK171504 VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · Recalled
- Descendant · 3 generations on · 8 of its ownK173488 CELERITY 20 HP Challenge PackSTERIS Corporation · 2018
- Descendant · 4 generations on · 8 of its ownK172752 CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018
Showing 5 of 20 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 20 · See all- K103331Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2011 · cites it directly15descendants
- K140499Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization ProcessesSTERIS Corporation · 2014 · 2 generations on14descendants
- K171504VERIFY Assert VH2O2 Self-Contained Biological IndicatorSTERIS Corporation · 2017 · 3 generations on9descendants
- K173488CELERITY 20 HP Challenge PackSTERIS Corporation · 2018 · 3 generations on8descendants
- K172752CELERITY 20 HP Biological IndicatorSTERIS Corporation · 2018 · 4 generations on8descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K042450 | Sterrad NX Challenge Pack | Advanced Sterilization Products | 2005 | — |
| −2 | K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | 2005 | — |
| −1 | K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | 2009 | — |
| 0 (this device) | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization | STERIS Corporation | 2009 | — |
| +1 | K103331 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization… | STERIS Corporation | 2011 | — |
| +2 | K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202… | STERIS Corporation | 2014 | — |
| +3 | K171504 | VERIFY Assert VH2O2 Self-Contained Biological Indicator | STERIS Corporation | 2017 | 1 |
| +3 | K173488 | CELERITY 20 HP Challenge Pack | STERIS Corporation | 2018 | — |
| +4 | K172752 | CELERITY 20 HP Biological Indicator | STERIS Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2014 | 2 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 3 | 0 |
| 2022 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 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? (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 |
|---|---|---|---|
| * | K073618 | Verify Sirius Biological Indicator Challenge PackSummary page 2…(21 CER 880.2800, FRC) 2. Predicate Device Verify Biological Indicator Challenge Pack for Vaporized PH20 Sterilization Processes, K073618, January 7, 2009. Cleared as Verify Sirius Biological Indicator Challenge Pack. 3. Description of Device The… | 2009 |
What descends from it? (20)
See all 202 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 4 years and passes through 2 companies; a new generation was cleared every 12 months on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K103331 (STERIS Corporation, 2011) has gone furthest, with 15 descendants of its own.
How does its category compare?
All FRC devicesFRC Indicator, Biological Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2009, 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 Biological Indicator Challenge Pack for Vaporized H2O Sterilization Processes is intended for qualification testing of the Amsco® V-PRO I (cleared under K073618) and Amsco V-PRO I Plus (Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included. The…
Read the full statement (116 words)
The Verify Biological Indicator Challenge Pack for Vaporized H2O Sterilization Processes is intended for qualification testing of the Amsco® V-PRO I (cleared under K073618) and Amsco V-PRO I Plus (Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs.
The challenge pack is placed in an otherwise empty sterilizer chamber; a hospital-defined challenge load is not included.
The challenge pack is not intended for routine monitoring of V-PRO Sterilizers. It has been tested and validated solely for use in periodic testing of the V-PRO I and V-PRO I Plus Sterilizers.
The Verify Biological Indicator Challenge Pack for Vaporized H2O Sterilization Processes is intended for qualification testing of the following cycles.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K092906 · printed Nov 6, 2026
Cite this page
510(k) Report. “K092906: Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K092906
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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