510(k) · Cleared
ClearedAlbert Browne LTD. Verify Steam Value Indicators
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 Mar 7, 2006 as substantially equivalent to K032801 (Albert Browne, Ltd., 2003) after a 53-day review. Its family tree reaches back 3 generations to 1994. 2 later devices descend from it.
- Decided
- Mar 7, 2006
- Review
- 53 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 3 generations to K932129 (1994). 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 deviceK060103 Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd. · 2006
- Descendant · cites it directly · 0 of its ownK112256 Steris Steam PISTERIS Corporation · 2012
- Descendant · cites it directly · 0 of its ownK061738 Albert Browne LTD. Verify Steam and EO Load Record CardAlbert Browne, Ltd. · 2006
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) | K060103 | Albert Browne LTD. Verify Steam Value Indicators | Albert Browne, Ltd. | 2006 | — |
| +1 | K112256 | Steris Steam PI | STERIS Corporation | 2012 | — |
| +1 | K061738 | Albert Browne LTD. Verify Steam and EO Load Record Card | Albert Browne, Ltd. | 2006 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2006 | 1 | 0 |
| 2012 | 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 |
|---|---|---|---|
| * | K032801 | Modified Browne Packaging and Label Steam Process IndicatorSummary page 1…1-ospital and Personal Use Devices Panel 3. PREDICATE DEVICE Modified B~rowne Packaging and Label Steamn Process Indicator (K032801) Albert Browne Ltd. Special 5 10(k) January II, 2006 VERIFY®D STEAM Value Indicators… | 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 12 years and passes through 2 companies; a new generation was cleared every 3.8 years on median.
- None of the 3 ancestors has a recall.
- Of its descendants, K112256 (STERIS Corporation, 2012) has gone furthest, with 0 descendants of its own.
- 1 other device also cites its predicate K032801.
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 Albert Browne Ltd. VERIFY® STEAM Value Indicators are process indicators that undergo 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/K060103 · printed Nov 4, 2026
Cite this page
510(k) Report. “K060103: Albert Browne LTD. Verify Steam Value Indicators.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 4, 2026. https://510kreport.com/device/K060103
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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