510(k) · Cleared
ClearedAlbert Browne LTD. Verify Steam and EO Load Record Card
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 Aug 25, 2006 as substantially equivalent to K991418 (Albert Browne, Ltd., 1999) and 2 other predicates after a 66-day review. Its family tree reaches back 4 generations to 1994.
- Decided
- Aug 25, 2006
- Review
- 66 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 3
Its longest line of descent runs back 4 generations to K932129 (1994). 6 ancestors in all. No later device cites it as a predicate yet.
- Root · 4 generations backK932129 3M Autoclave Tapes3M Company · 1994
- 3 generations backK992767 Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2000
- 2 generations backK032801 Modified Browne Packaging and Label Steam Process IndicatorAlbert Browne, Ltd. · 2003
- 1 generation backK060103 Albert Browne LTD. Verify Steam Value IndicatorsAlbert Browne, Ltd. · 2006
- This deviceK061738 Albert Browne LTD. Verify Steam and EO Load Record CardAlbert Browne, Ltd. · 2006
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −4 | K932129 | 3M Autoclave Tapes | 3M Company | 1994 | — |
| −3 | K992767 | Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2000 | — |
| −2 | K032801 | Modified Browne Packaging and Label Steam Process Indicator | Albert Browne, Ltd. | 2003 | — |
| −1 | K060103 | Albert Browne LTD. Verify Steam Value Indicators | Albert Browne, Ltd. | 2006 | — |
| 0 (this device) | K061738 | Albert Browne LTD. Verify Steam and EO Load Record Card | Albert Browne, Ltd. | 2006 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1999 | 1 | 0 |
| 2000 | 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? (3)
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 |
|---|---|---|---|
| * | K991418 | Browne Mvi Ethylene Oxide IndicatorSummary page 1…J) by the General Hospital and Personal Use Devices Panel 3. PREDICATE DEVICES * Browne MVI Ethylene Oxide Indicator (K991418) * Albert Browne, Ltd. VERIFY® STEAM Value Indicators (K060103) * Steam/EO Record Card (K000502) Albert B… | 1999 |
| * | K060103 | Albert Browne LTD. Verify Steam Value IndicatorsSummary page 1…al Use Devices Panel 3. PREDICATE DEVICES * Browne MVI Ethylene Oxide Indicator (K991418) * Albert Browne, Ltd. VERIFY® STEAM Value Indicators (K060103) * Steam/EO Record Card (K000502) Albert Browne Ltd. August 10, 2006 Additional Information - K… | 2006 |
| * | K000502 | Steam/EO Record Card, Model CI 121Summary page 1…CES * Browne MVI Ethylene Oxide Indicator (K991418) * Albert Browne, Ltd. VERIFY® STEAM Value Indicators (K060103) * Steam/EO Record Card (K000502) Albert Browne Ltd. August 10, 2006 Additional Information - K06 1738… | 2000 |
What descends from it?
No later submission names this one as a predicate yet.
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 6 ancestors has a recall.
- 1 other device also cites its predicate K991418.
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 and EO Load Record Card 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) or an ethylene oxide sterilization process.
Indications for use read by OCR from a scanned FDA summary, so letters may be misread. Check the PDF before quoting it.
https://510kreport.com/device/K061738 · printed Nov 5, 2026
Cite this page
510(k) Report. “K061738: Albert Browne LTD. Verify Steam and EO Load Record Card.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K061738
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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