510(k) · Cleared
ClearedVerify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization Processes
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Sep 1, 2011 as substantially equivalent to K092906 (STERIS Corporation, 2009) after a 293-day review. Its family tree reaches back 4 generations to 2005. 15 later devices descend from it.
- Decided
- Sep 1, 2011
- Review
- 293 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 4 generations to K042450 (2005). 15 later devices descend from it, 1 citing it directly.
- Root · 4 generations backK042450 Sterrad NX Challenge PackAdvanced Sterilization Products · 2005
- 3 generations backK051643 Sterrad Sterilizer Cyclesure Test PackAdvanced Sterilization Products · 2005
- 2 generations backK073618 Verify Sirius Biological Indicator Challenge PackSTERIS Corporation · 2009
- 1 generation backK092906 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2009
- This deviceK103331 Verify Biological Indicator Challenge Pack for Vaporized VH202…STERIS Corporation · 2011
- 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 15 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 15 · 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 |
|---|---|---|---|---|---|
| −4 | K042450 | Sterrad NX Challenge Pack | Advanced Sterilization Products | 2005 | — |
| −3 | K051643 | Sterrad Sterilizer Cyclesure Test Pack | Advanced Sterilization Products | 2005 | — |
| −2 | K073618 | Verify Sirius Biological Indicator Challenge Pack | STERIS Corporation | 2009 | — |
| −1 | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization | STERIS Corporation | 2009 | — |
| 0 (this device) | K103331 | Verify Biological Indicator Challenge Pack for Vaporized VH202 Sterilization… | STERIS Corporation | 2011 | — |
| +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 |
|---|---|---|
| 2014 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 4 | 0 |
| 2019 | 2 | 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 JOJ? 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 JOJ device
- #1 K261992 3M™ Attest™ Steam Chemical Integrator (1243A…score 13.3 · 5 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 |
|---|---|---|---|
| * | K092906 | Verify Biological Indicator Challenge Pack for Vaporized VH202 SterilizationSummary page 3…for Vaporized H0Sterilization Processes is intended for qualification testing of the Amsco' V-PRO 1, the Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906) and the V-PROT maX (Flexible, Lumen and Non Lumen Cycles) Low Temperature Sterilization Systems following installation… | 2009 |
What descends from it? (15)
See all 151 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K140499 | Verify V24 Self-Contained Biological Indicator for Vaporized VH202 Sterilization Processes | 2014 | 14 |
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 1.7 years on median.
- None of the 4 ancestors has a recall.
- Of its descendants, K140499 (STERIS Corporation, 2014) has gone furthest, with 14 descendants of its own.
- 1 other device also cites its predicate K092906.
How does its category compare?
All JOJ devicesJOJ Indicator, Physical/Chemical Sterilization Process: FDA decisions, review times, recalls and adverse event reports over 20 years. 2011, this device’s year, is highlighted.
FDA decisions per year · JOJ
6in 2025
2026 to Oct 25, outlined.
Median 510(k) review, days · JOJ
90in 2025
Receipt to decision; years with fewer than 3 clearances left blank.
Recalls per year · JOJ
1in 2023
Class I (0 since 2007) Class II/III not classified
Adverse event reports per year · JOJ
12in 2025
MAUDE reports naming product code JOJ, 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 | 8 | 140 | 0 | 1 |
| 2008 | 9 | 57 | 2 | 1 |
| 2009 | 7 | 188 | 2 | 9 |
| 2010 | 6 | 115 | 0 | 3 |
| 2011 | 13 | 151 | 2 | 1 |
| 2012 | 7 | 224 | 0 | 8 |
| 2013 | 6 | 212 | 0 | 6 |
| 2014 | 6 | 198 | 0 | 11 |
| 2015 | 8 | 188 | 0 | 7 |
| 2016 | 4 | 150 | 0 | 11 |
| 2017 | 7 | 172 | 0 | 35 |
| 2018 | 5 | 150 | 0 | 12 |
| 2019 | 12 | 38 | 0 | 8 |
| 2020 | 7 | 108 | 0 | 6 |
| 2021 | 4 | 87 | 1 | 29 |
| 2022 | 8 | 90 | 0 | 23 |
| 2023 | 4 | 53 | 1 | 39 |
| 2024 | 12 | 71 | 0 | 25 |
| 2025 | 6 | 90 | 0 | 12 |
| 2026 | 3 | 30 | 0 | — |
What is it indicated for?
The Verify Biological Indicator Challenge Pack for Vaporized H20 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618), Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906), and Amsco V-PRO maX (Lumen, Non Lumen and Flexible Cycles) Low Temperature Sterilization Systems following installation, relocation, malfunctions or major repairs. The challenge pack is placed in an otherwise empty sterilizer…
Read the full statement (188 words)
The Verify Biological Indicator Challenge Pack for Vaporized H20 Sterilization Processes is intended for qualification testing of the Amsco® V-PRO™ 1 (cleared under K073618), Amsco V-PRO 1 Plus (Lumen and Non Lumen Cycles, K092906), and Amsco V-PRO maX (Lumen, Non Lumen and Flexible 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 1, V-PRO 1 Plus and V-PRO maX Sterilizers.
The Verify Biological Indicator Challenge Pack for Vaporized H120 Sterilization Processes is intended for qualification testing of the following cycles:
Amsco V-PRO 1 Cycle
Amsco V-PRO 1 Plus Lumen Cycle — sterilant/injection 2.1; 4 injections; exposure time 32 min
Amsco V-PRO maX Lumen Cycle
Amsco V-PRO 1 Plus Non Lumen Cycle — sterilant/injection 2.1; 4 injections; exposure time 12 min
Amsco V-PRO maX Non Lumen Cycle
Amsco V-PRO maX Flexible Cycle — sterilant/injection 2.1; 4 injections; exposure time 12 min
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K103331 · printed Nov 6, 2026
Cite this page
510(k) Report. “K103331: Verify Biological Indicator Challenge Pack for Vaporized VH202 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/K103331
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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