510(k) · Cleared
ClearedBrowne Mvi Ethylene Oxide 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 Jun 10, 1999 after a 48-day review. The FDA summary names its predicate without a number. 3 later devices descend from it.
- Decided
- Jun 10, 1999
- Review
- 48 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
3 later devices descend from it, 2 citing it directly.
- This deviceK991418 Browne Mvi Ethylene Oxide IndicatorAlbert Browne, Ltd. · 1999
- Descendant · cites it directly · 1 of its ownK150644 AN85/AN86 EO IndicatorsAndersen Sterilizers, Inc. · 2015
- Descendant · 2 generations on · 0 of its ownK170426 AN85/AN86 EO IndicatorsAndersen Sterilizers, Inc. · 2017
- 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 3 of 3 · See all- K150644AN85/AN86 EO IndicatorsAndersen Sterilizers, Inc. · 2015 · cites it directly1descendant
- K170426AN85/AN86 EO IndicatorsAndersen Sterilizers, Inc. · 2017 · 2 generations on0descendants
- K061738Albert Browne LTD. Verify Steam and EO Load Record CardAlbert Browne, Ltd. · 2006 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K991418 | Browne Mvi Ethylene Oxide Indicator | Albert Browne, Ltd. | 1999 | — |
| +1 | K150644 | AN85/AN86 EO Indicators | Andersen Sterilizers, Inc. | 2015 | — |
| +2 | K170426 | AN85/AN86 EO Indicators | Andersen Sterilizers, Inc. | 2017 | — |
| +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 |
| 2015 | 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 |
|---|---|---|---|
| * | — | Gas-Chex® Sterilization Indicator Strips, Propper Mfg. Corp. Named without a submission number |
What descends from it? (3)
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, K150644 (Andersen Sterilizers, Inc., 2015) has gone furthest, with 1 descendant 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 Browne MVI Ethylene Oxide Indicator is a process indicator designed to indicate,
through a visible color change, when the device has been exposed to 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/K991418 · printed Nov 6, 2026
Cite this page
510(k) Report. “K991418: Browne Mvi Ethylene Oxide Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K991418
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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