510(k) · Cleared
ClearedBrowne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution
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 Feb 4, 1999 as substantially equivalent to K922481 (Board of Directors, Albert Browne, Ltd., 1994) after a 37-day review. Its family tree reaches back 1 generation to 1994.
- Decided
- Feb 4, 1999
- Review
- 37 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K922481 (1994). No later device cites it as a predicate yet.
- Root · 1 generation backK922481 Browne GA Indicator Use in 2% Activ GlutaraldehydeBoard of Directors, Albert Browne, Ltd. · 1994 · Recalled
- This deviceK984616 Browne Sporicidin Glutaraldehyde Indicator for Sporicidin…Albert Browne, Ltd. · 1999
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) | K984616 | Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and… | Albert Browne, Ltd. | 1999 | — |
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…n/Usual Name: Browne Sporicidin Glutaraldehyde Indicator Classification Name: Physical/Chemical Sterilization Process Indicator 3. PREDICATE DEVICE Browne GA Indicator (K922481, Albert Browne Ltd.) 4, INTENDED USE The Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting… | 1994 |
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?
- Its one ancestor has a recall.
- 4 other devices also cite its predicate K922481.
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 Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting
Solution (Browne Sporicidin Glutaraldehyde Indicator) is a glutaraldehyde concentration
monitor for use in glutaraldehyde-containing germicide solutions with a minimum effective
concentration of 0.6% glutaraldehyde.
The Browne Sporicidin Glutaraldehyde Indicator is dedicated for use with Sporicidin
Sterilizing and Disinfecting 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/K984616 · printed Nov 5, 2026
Cite this page
510(k) Report. “K984616: Browne Sporicidin Glutaraldehyde Indicator for Sporicidin Sterilizing and Disinfecting Solution.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K984616
Report an extraction error
Are you the manufacturer?
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