510(k) · Cleared
ClearedBrowne TST Single Use Bowie Dick/Integrator Test Pack
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Albert Browne, Ltd. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jul 3, 2002 after a 670-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 4 later devices descend from it.
- Decided
- Jul 3, 2002
- Review
- 670 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
4 later devices descend from it, 2 citing it directly.
- This deviceK002741 Browne TST Single Use Bowie Dick/Integrator Test PackAlbert Browne, Ltd. · 2002
- Descendant · cites it directly · 3 of its ownK070895 Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3…STERIS Corporation · 2007
- Descendant · 2 generations on · 2 of its ownK073683 Verify Challenge Packs - Version 2STERIS Corporation · 2008
- Descendant · 3 generations on · 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 4 of 4 · See all- K070895Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10…STERIS Corporation · 2007 · cites it directly3descendants
- K073683Verify Challenge Packs - Version 2STERIS Corporation · 2008 · 2 generations on2descendants
- K103053Verify 270FP Challenge PackSTERIS Corporation · 2011 · 3 generations on1descendant
- K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…STERIS Corporation · 2017 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K002741 | Browne TST Single Use Bowie Dick/Integrator Test Pack | Albert Browne, Ltd. | 2002 | — |
| +1 | K070895 | Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack… | STERIS Corporation | 2007 | — |
| +2 | K073683 | Verify Challenge Packs - Version 2 | STERIS Corporation | 2008 | — |
| +3 | 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 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2017 | 1 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (4)
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?
- Of its descendants, K070895 (STERIS Corporation, 2007) has gone furthest, with 3 descendants 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.
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 | — |
https://510kreport.com/device/K002741 · printed Nov 5, 2026
Cite this page
510(k) Report. “K002741: Browne TST Single Use Bowie Dick/Integrator 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/K002741
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026