510(k) · Cleared
ClearedSerim Peracetic Acid Reagent 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 May 1, 1991 after a 97-day review. FDA has not posted a summary or statement for it, so its predicates are not known. 11 later devices descend from it.
- Decided
- May 1, 1991
- Review
- 97 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 0
11 later devices descend from it, 2 citing it directly.
- This deviceK910320 Serim Peracetic Acid Reagent StripsSerim Research Corp. · 1991
- Descendant · cites it directly · 9 of its ownK972035 Sporox Test StripsSerim Research Corp. · 1997
- Descendant · 2 generations on · 8 of its ownK081600 Steris Resert XL Test StripSTERIS Corporation · 2008
- 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
- Descendant · 5 generations on · 1 of its ownK240032 Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024
Showing 5 of 11 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 11 · See all- K972035Sporox Test StripsSerim Research Corp. · 1997 · cites it directly9descendants
- K081600Steris Resert XL Test StripSTERIS Corporation · 2008 · 2 generations on8descendants
- K102217System 1E Chemical IndicatorSTERIS Corporation · 2010 · 3 generations on5descendants
- K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018 · 4 generations on3descendants
- K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024 · 5 generations on1descendant
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K910320 | Serim Peracetic Acid Reagent Strips | Serim Research Corp. | 1991 | — |
| +1 | K972035 | Sporox Test Strips | Serim Research Corp. | 1997 | — |
| +2 | K081600 | Steris Resert XL Test Strip | STERIS Corporation | 2008 | — |
| +3 | K102217 | System 1E Chemical Indicator | STERIS Corporation | 2010 | — |
| +4 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018 | — |
| +5 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1997 | 1 | 0 |
| 2008 | 1 | 0 |
| 2010 | 1 | 0 |
| 2011 | 1 | 0 |
| 2015 | 1 | 0 |
| 2018 | 1 | 0 |
| 2020 | 1 | 0 |
| 2023 | 2 | 0 |
| 2024 | 2 | 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 has not posted a summary or statement for it, so its predicates are not known.
What descends from it? (11)
See all 112 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, K972035 (Serim Research Corp., 1997) has gone furthest, with 9 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/K910320 · printed Nov 6, 2026
Cite this page
510(k) Report. “K910320: Serim Peracetic Acid Reagent Strips.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K910320
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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