510(k) · Cleared
ClearedModified Browne Packaging and Label Steam Process Indicator
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 Oct 17, 2003 as substantially equivalent to K992767 (Albert Browne, Ltd., 2000) after a 38-day review. Its family tree reaches back 2 generations to 1994. 6 later devices descend from it.
- Decided
- Oct 17, 2003
- Review
- 38 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 2 generations to K932129 (1994). 6 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 1 generation backK992767 Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000
- This deviceK032801 Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003
- Descendant · cites it directly · 2 of its ownK073683 Verify Challenge Packs - Version 2STERIS Corporation · 2008
- Descendant · cites it directly · 2 of its ownK060103 Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd. · 2006
- 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
- Descendant · 2 generations on · 0 of its ownK112256 Steris Steam PISTERIS Corporation · 2012
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K073683Verify Challenge Packs - Version 2STERIS Corporation · 2008 · cites it directly2descendants
- K060103Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd. · 2006 · 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
- K112256Steris Steam PISTERIS Corporation · 2012 · 2 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −1 | K992767 | Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2000 | — |
| 0 (this device) | K032801 | Modified Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2003 | — |
| +1 | K073683 | Verify Challenge Packs - Version 2 | STERIS Corporation | 2008 | — |
| +1 | K060103 | Albert Browne LTD. Verify Steam Value Indicators | Albert Browne, Ltd. | 2006 | — |
| +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 |
| +2 | K112256 | Steris Steam PI | STERIS Corporation | 2012 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 2 | 0 |
| 2008 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K992767 | Browne Packaging and Label Steam Process IndicatorSummary page 1…Hospital and Personal Use Devices Panel 3. DEVICE PREDICATE Browne Packaging and Label Steam Process Indicator (K992767) Albert Browne Ltd. Special 5 1O(k) September 8,2003 Modified Packaging and Label Steam Indicator A… | 2000 |
What descends from it? (6)
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 9 years and passes through 2 companies; a new generation was cleared every 5.9 years on median.
- None of the 2 ancestors has a recall.
- Of its descendants, K073683 (STERIS Corporation, 2008) has gone furthest, with 2 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 | — |
What is it indicated for?
The Modified Browne Packaging and Label Steam Process Indicator is a process indicator
which undergoes a visual color change when exposed to steam in a temperature range of
121°C to 135°C (250°F to 275°F).
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K032801 · printed Nov 6, 2026
Cite this page
510(k) Report. “K032801: Modified Browne Packaging and Label Steam Process Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K032801
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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