510(k) · Cleared
ClearedVerify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10 Challenge Pack
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 5, 2007 as substantially equivalent to K002741 (Albert Browne, Ltd., 2002) after a 159-day review. Its family tree reaches back 1 generation to 2002. 3 later devices descend from it.
- Decided
- Sep 5, 2007
- Review
- 159 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K002741 (2002). 3 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK002741 Browne TST Single Use Bowie Dick/Integrator Test PackAlbert Browne, Ltd. · 2002
- This deviceK070895 Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3…STERIS Corporation · 2007
- Descendant · cites it directly · 2 of its ownK073683 Verify Challenge Packs - Version 2STERIS Corporation · 2008
- Descendant · 2 generations on · 1 of its ownK103053 Verify 270FP Challenge PackSTERIS Corporation · 2011 · Recalled
- Descendant · 2 generations on · 0 of its ownK162758 VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators…STERIS Corporation · 2017 · Recalled
Most influential descendants
Showing 3 of 3 · See all- K073683Verify Challenge Packs - Version 2STERIS Corporation · 2008 · cites it directly2descendants
- K103053Verify 270FP Challenge PackSTERIS Corporation · 2011 · 2 generations on1descendant
- K162758VERIFY SixCess Steam Indicators, VERIFY SixCess Flash Indicators, VERIFY Bowie Dick Test…STERIS Corporation · 2017 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K002741 | Browne TST Single Use Bowie Dick/Integrator Test Pack | Albert Browne, Ltd. | 2002 | — |
| 0 (this device) | K070895 | Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack… | STERIS Corporation | 2007 | — |
| +1 | K073683 | Verify Challenge Packs - Version 2 | STERIS Corporation | 2008 | — |
| +2 | K103053 | Verify 270FP Challenge Pack | STERIS Corporation | 2011 | 1 |
| +2 | 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 |
|---|---|---|
| 2008 | 1 | 0 |
| 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? (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 |
|---|---|---|---|
| * | K002741 | Browne TST Single Use Bowie Dick/Integrator Test PackSummary page 2…(21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Devices · STERIS Integrator Challenge Pack (Model LCCO03) -K002741 3. Device Description The proposed Verify® Challenge Packs consist of an emulating indicator surrounded by a st… | 2002 |
What descends from it? (3)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K073683 | Verify Challenge Packs - Version 2 | 2008 | 2 |
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?
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. 2007, 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 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:
MODEL TEMPERATURESTERILiZATIONTYPE TIME
Verify® 270F 4 270°F (132°C) Pre-vacuum, Steam Flush 4 minutes
Pressure Pulse (SFPP)
Verify® 275F 3 275 0 F (135°C) Pre-vacuum 3 minutes
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K070895 · printed Nov 4, 2026
Cite this page
510(k) Report. “K070895: Verify Challenge Packs, Models 270F 4 Challenge Pack; 275F 3 Challenge Pack; 275F 10 Challenge Pack.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K070895
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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