510(k) · Cleared
ClearedVerify Challenge Packs - Version 2
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 Jan 25, 2008 as substantially equivalent to K070895 (STERIS Corporation, 2007) and 1 other predicate after a 28-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Jan 25, 2008
- Review
- 28 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K932129 (1994). 5 ancestors in all. 2 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 2 generations backK992767 Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000
- 1 generation backK032801 Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003
- This deviceK073683 Verify Challenge Packs - Version 2STERIS Corporation · 2008
- Descendant · cites it directly · 1 of its ownK103053 Verify 270FP Challenge PackSTERIS Corporation · 2011 · Recalled
- Descendant · cites it directly · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled
Most influential descendants
Showing 2 of 2 · See allView FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −2 | K992767 | Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2000 | — |
| −1 | K032801 | Modified Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2003 | — |
| 0 (this device) | K073683 | Verify Challenge Packs - Version 2 | STERIS Corporation | 2008 | — |
| +1 | K103053 | Verify 270FP Challenge Pack | STERIS Corporation | 2011 | 1 |
| +1 | K162758 | VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie… | STERIS Corporation | 2017 | 1 |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2002 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2011 | 1 | 0 |
| 2017 | 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? (2)
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 |
|---|---|---|---|
| * | K070895 | Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10…Summary page 2…l sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Devices • Verify® Challenge Packs - K070895. * Modified Browne Packaging and Label Steam Process Indicator- K032801. 3. Device Description The proposed Verify… | 2007 |
| * | K032801 | Modified Browne Packaging and Label Steam Process IndicatorSummary page 2…880.2800 (b), Product Code JOJ). 2. Predicate Devices • Verify® Challenge Packs - K070895. * Modified Browne Packaging and Label Steam Process Indicator- K032801. 3. Device Description The proposed Verify® Challenge Packs - Version 2 -consist of an emulating indicator surroun… | 2003 |
What descends from it? (2)
2 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 14 years and passes through 3 companies; a new generation was cleared every 4.3 years on median.
- None of the 5 ancestors has a recall.
- Of its descendants, K103053 (STERIS Corporation, 2011) has gone furthest, with 1 descendant of its own.
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. 2008, 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® Challenge Packs -Version 2 -. are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are: Verify 270F 4 270°F (132°C) Pre-vacuum, Steam Flush…
Read the full statement (110 words)
The Verify® Challenge Packs -Version 2 -. are test packs consisting of an emulating indicator surrounded by a steam penetration barrier, intended for use in steam sterilization. The Verify® Challenge Packs indicators change color from yellow to blue/purple when exposed to the appropriate cycle temperature, type, and duration. The challenge pack models and their cycle temperatures, types, and times are:
Verify 270F 4 270°F (132°C) Pre-vacuum, Steam Flush Pressure Pulse (SFPP) 4 minutes
Verify 275F 3 275°F (135°C) Pre-vacuum 3 minutes
There is a process indicator outside of the packs which undergoes a visual color change when exposed to steam in a temperature range of 250°F (121°C) to 275°F (135°C).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K073683 · printed Nov 6, 2026
Cite this page
510(k) Report. “K073683: Verify Challenge Packs - Version 2.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K073683
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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