510(k) · Cleared
Recalled · 2003Browne GA Indicator Use in 2% Activ Glutaraldehyde
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Board of Directors, Albert Browne, Ltd. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jun 2, 1994 after a 737-day review. FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known. 22 later devices descend from it. It has been recalled 3 times.
- Decided
- Jun 2, 1994
- Review
- 737 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 3
- Predicates
- 0
22 later devices descend from it, 5 citing it directly.
- This deviceK922481 Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 1994
- Descendant · cites it directly · 10 of its ownK012335 Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and…Albert Browne, Ltd. · 2001
- Descendant · 2 generations on · 8 of its ownK081600 Steris Resert XL Test StripSTERIS Corporation · 2008
- Descendant · cites it directly · 6 of its ownK991709 Browne Cidex Opa IndicatorAlbert Browne, Ltd. · 1999 · Recalled
- Descendant · 3 generations on · 5 of its ownK102217 System 1E Chemical IndicatorSTERIS Corporation · 2010
- Descendant · 4 generations on · 3 of its ownK173428 VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018
Showing 5 of 22 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 22 · See all- K012335Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30…Albert Browne, Ltd. · 2001 · cites it directly10descendants
- K081600Steris Resert XL Test StripSTERIS Corporation · 2008 · 2 generations on8descendants
- K991709Browne Cidex Opa IndicatorAlbert Browne, Ltd. · 1999 · cites it directly6descendants
- K102217System 1E Chemical IndicatorSTERIS Corporation · 2010 · 3 generations on5descendants
- K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018 · 4 generations on3descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K922481 | Browne GA Indicator Use in 2% Activ Glutaraldehyde | Board of Directors, Albert Browne, Ltd. | 1994 | — |
| +1 | K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide… | Albert Browne, Ltd. | 2001 | — |
| +2 | K081600 | Steris Resert XL Test Strip | STERIS Corporation | 2008 | — |
| +1 | K991709 | Browne Cidex Opa Indicator | Albert Browne, Ltd. | 1999 | 1 |
| +3 | K102217 | System 1E Chemical Indicator | STERIS Corporation | 2010 | — |
| +4 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1998 | 1 | 0 |
| 1999 | 3 | 0 |
| 2001 | 1 | 0 |
| 2008 | 3 | 0 |
| 2009 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2012 | 1 | 0 |
| 2015 | 1 | 0 |
| 2017 | 1 | 0 |
| 2018 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 3 | 0 |
Sources: FDA 510(k) database (decision fields), 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?
FDA lists a 510(k) statement for it but has not posted the file, so its predicates are not known.
What descends from it? (22)
See all 225 later devices cite it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30… | 2001 | 10 |
| K991709 | Browne Cidex Opa Indicator | 1999 | 6 |
| K981054 | Browne GA Indicator for Cidex Products | 1998 | 1 |
| K984616 | Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting… | 1999 | 0 |
| K984613 | Browne Sporicidin Phenol Indicator for Sporicidin Sterilizing and Disinfecting Solution | 1999 | 0 |
Has anything in its family been recalled? (0 Class I)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2003 | Not classified | Z-1480-04 | Other | Performance failure complaints. |
| Feb 25, 2003 | Not classified | Z-0712-03 | Other | Moisture ingress into packaging of test strips may cause premature failure. |
| Feb 14, 2003 | Not classified | Z-0694-03 | Other | Test strips which are used for QC of sterilant solution fail prematurely due to ingress of moisture. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
- Of its descendants, K012335 (Albert Browne, Ltd., 2001) has gone furthest, with 10 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 | — |
https://510kreport.com/device/K922481 · printed Nov 6, 2026
Cite this page
510(k) Report. “K922481: Browne GA Indicator Use in 2% Activ Glutaraldehyde.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K922481
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Record history
- FDA decision record loaded May 2, 2026
- Lineage and recalls computed Nov 3, 2026
- Page last updated Nov 3, 2026