510(k) · Cleared
ClearedSporox Test Strips
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Serim Research Corp. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Aug 29, 1997 as substantially equivalent to K910320 (Serim Research Corp., 1991) after an 88-day review. Its family tree reaches back 1 generation to 1991. 9 later devices descend from it.
- Decided
- Aug 29, 1997
- Review
- 88 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K910320 (1991). 9 later devices descend from it, 1 citing it directly.
- Root · 1 generation backK910320 Serim Peracetic Acid Reagent StripsSerim Research Corp. · 1991
- This deviceK972035 Sporox Test StripsSerim Research Corp. · 1997
- Descendant · cites it directly · 8 of its ownK081600 Steris Resert XL Test StripSTERIS Corporation · 2008
- Descendant · 2 generations on · 5 of its ownK102217 System 1E Chemical IndicatorSTERIS Corporation · 2010
- Descendant · 3 generations on · 3 of its ownK173428 VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018
- Descendant · 4 generations on · 1 of its ownK240032 Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024
- Descendant · 2 generations on · 1 of its ownK102296 Verify Chemical Monitoring Strip for Resert Soultions (Resert XL…STERIS Corporation · 2011
Showing 5 of 9 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 9 · See all- K081600Steris Resert XL Test StripSTERIS Corporation · 2008 · cites it directly8descendants
- K102217System 1E Chemical IndicatorSTERIS Corporation · 2010 · 2 generations on5descendants
- K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018 · 3 generations on3descendants
- K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024 · 4 generations on1descendant
- K102296Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2)STERIS Corporation · 2011 · 2 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K910320 | Serim Peracetic Acid Reagent Strips | Serim Research Corp. | 1991 | — |
| 0 (this device) | K972035 | Sporox Test Strips | Serim Research Corp. | 1997 | — |
| +1 | K081600 | Steris Resert XL Test Strip | STERIS Corporation | 2008 | — |
| +2 | K102217 | System 1E Chemical Indicator | STERIS Corporation | 2010 | — |
| +3 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018 | — |
| +4 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024 | — |
| +2 | K102296 | Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip… | STERIS Corporation | 2011 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 |
|---|---|---|---|
| * | K910320 | Serim Peracetic Acid Reagent StripsSummary page 1…lar in design, composition, and function to the Peracetic Acid Reagent Strips manufactured by Serim Research Corporation which was the subject of Premarket Notification #K910320A. The product is similar in utility to a titrimetric assay. Supportive data for substantial equivalence to the latter was obtaine… | 1991 |
What descends from it? (9)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K081600 | Steris Resert XL Test Strip | 2008 | 8 |
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?
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?
SPOROX™ Test Strips provide a rapid, convenient semi-quantitative
means of indicating whether effective concentrations of hydrogen
peroxide are present in SPOROX® Sterilizing and Disinfecting
Solution. The SPOROX™ Test Strips indicate concentrations of
hydrogen peroxide but do not confirm disinfection or
sterilization.
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/K972035 · printed Nov 6, 2026
Cite this page
510(k) Report. “K972035: Sporox Test Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K972035
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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