510(k) · Cleared
Recalled · 2003Browne Cidex Opa 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 8, 1999 as substantially equivalent to K922481 (Board of Directors, Albert Browne, Ltd., 1994) after a 142-day review. Its family tree reaches back 1 generation to 1994. 6 later devices descend from it. It has been recalled once.
- Decided
- Oct 8, 1999
- Review
- 142 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- 1
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922481 (1994). 6 later devices descend from it, 3 citing it directly.
- Root · 1 generation backK922481 Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 1994 · Recalled
- This deviceK991709 Browne Cidex Opa IndicatorAlbert Browne, Ltd. · 1999
- Descendant · cites it directly · 2 of its ownK081370 Serim Disintek Opa Test StripSerim Research Corp. · 2008
- Descendant · cites it directly · 2 of its ownK081427 Browne Opa Test StripSTERIS Corporation · 2008
- Descendant · 2 generations on · 0 of its ownK241344 MetriCide™ OPA Plus Solution Test StripSteris · 2024
- Descendant · 2 generations on · 0 of its ownK202565 WAVICIDE-OPA MEC IndicatorSerim Research Corporation · 2020
- Descendant · cites it directly · 0 of its ownK181472 AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC…Advanced Sterilization Products (Asp) · 2019
Showing 5 of 6 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 6 · See all- K081370Serim Disintek Opa Test StripSerim Research Corp. · 2008 · cites it directly2descendants
- K081427Browne Opa Test StripSTERIS Corporation · 2008 · cites it directly2descendants
- K241344MetriCide™ OPA Plus Solution Test StripSteris · 2024 · 2 generations on0descendants
- K202565WAVICIDE-OPA MEC IndicatorSerim Research Corporation · 2020 · 2 generations on0descendants
- K181472AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC MonitorAdvanced Sterilization Products (Asp) · 2019 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K922481 | Browne GA Indicator Use in 2% Activ Glutaraldehyde | Board of Directors, Albert Browne, Ltd. | 1994 | 3 |
| 0 (this device) | K991709 | Browne Cidex Opa Indicator | Albert Browne, Ltd. | 1999 | — |
| +1 | K081370 | Serim Disintek Opa Test Strip | Serim Research Corp. | 2008 | — |
| +1 | K081427 | Browne Opa Test Strip | STERIS Corporation | 2008 | — |
| +2 | K241344 | MetriCide™ OPA Plus Solution Test Strip | Steris | 2024 | — |
| +2 | K202565 | WAVICIDE-OPA MEC Indicator | Serim Research Corporation | 2020 | — |
| +1 | K181472 | AEROFLEX (TM) Automatic Endoscope Reprocessor with AUTOSURE (TM) MRC Monitor | Advanced Sterilization Products (Asp) | 2019 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 2 | 0 |
| 2012 | 1 | 0 |
| 2019 | 1 | 0 |
| 2020 | 1 | 0 |
| 2024 | 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 |
|---|---|---|---|
| * | K922481 | Browne GA Indicator Use in 2% Activ GlutaraldehydeSummary page 1…rtho-Phthalaldehyde Concentration Indicator Classification Name: Physical/Chemical Sterilization Process Indicator 3. PREDICATE DEVICES Browne GA Indicator, subject of K922481 4. INTENDED USE The Browne Cidex™ OPA Indicator (Browne OPA Indicator) is a concentration monitor for use in ortho-phthalaldehyd… | 1994 |
What descends from it? (6)
3 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)
Recalls of this device
| Date | Class | Recall | Root cause | Reason |
|---|---|---|---|---|
| Sep 4, 2003 | Not classified | Z-1481-04 | Other | Performance failure complaints. |
No ancestor or descendant has a Class I recall.
What does this lineage say?
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 Cidex™ OPA Indicator is a concentration monitor for use in ortho-
phthalalclehyde-containing germicide solutions with a minimum effective concentration of
0.3%.
The Browne Cidex™ OPA Indicator is dedicated for use with Cidex™ OPA Solution.
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/K991709 · printed Nov 5, 2026
Cite this page
510(k) Report. “K991709: Browne Cidex Opa Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K991709
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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