510(k) · Cleared
ClearedSteris Resert XL Test Strip
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
STERIS Corporation · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Aug 22, 2008 as substantially equivalent to K972035 (Serim Research Corp., 1997) and 1 other predicate after a 77-day review. Its family tree reaches back 2 generations to 1991. 8 later devices descend from it.
- Decided
- Aug 22, 2008
- Review
- 77 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 2 generations to K910320 (1991). 4 ancestors in all. 8 later devices descend from it, 2 citing it directly.
- Root · 2 generations backK910320 Serim Peracetic Acid Reagent StripsSerim Research Corp. · 1991
- 1 generation backK972035 Sporox Test StripsSerim Research Corp. · 1997
- This deviceK081600 Steris Resert XL Test StripSTERIS Corporation · 2008
- Descendant · cites it directly · 5 of its ownK102217 System 1E Chemical IndicatorSTERIS Corporation · 2010
- Descendant · 2 generations on · 3 of its ownK173428 VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018
- Descendant · 3 generations on · 1 of its ownK240032 Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024
- Descendant · cites it directly · 1 of its ownK102296 Verify Chemical Monitoring Strip for Resert Soultions (Resert XL…STERIS Corporation · 2011
- Descendant · 4 generations on · 0 of its ownK243475 Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation · 2024
Showing 5 of 8 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 8 · See all- K102217System 1E Chemical IndicatorSTERIS Corporation · 2010 · cites it directly5descendants
- K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018 · 2 generations on3descendants
- K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024 · 3 generations on1descendant
- K102296Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip Version 2)STERIS Corporation · 2011 · cites it directly1descendant
- K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation · 2024 · 4 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −2 | K910320 | Serim Peracetic Acid Reagent Strips | Serim Research Corp. | 1991 | — |
| −1 | K972035 | Sporox Test Strips | Serim Research Corp. | 1997 | — |
| 0 (this device) | K081600 | Steris Resert XL Test Strip | STERIS Corporation | 2008 | — |
| +1 | K102217 | System 1E Chemical Indicator | STERIS Corporation | 2010 | — |
| +2 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018 | — |
| +3 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024 | — |
| +1 | K102296 | Verify Chemical Monitoring Strip for Resert Soultions (Resert XL Test Strip… | STERIS Corporation | 2011 | — |
| +4 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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? (2)
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 |
|---|---|---|---|
| * | K972035 | Sporox Test StripsSummary page 2…Physical/chemical sterilization process indicator (21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Devices * K972035 - SPOROXTM Test Strips * K012335 - Browne Metrex 1.8% Glutaraldehyde Indicator 3. Description of Device The STER… | 1997 |
| * | K012335 | Browne Metrex 1.8% Glutaraldehyde Indicator for Metricide 28 and Metricide Plus 30…Summary page 2…rocess indicator (21 CFR 880.2800 (b), Product Code JOJ). 2. Predicate Devices * K972035 - SPOROXTM Test Strips * K012335 - Browne Metrex 1.8% Glutaraldehyde Indicator 3. Description of Device The STERIS Resert XL Test Strip is a chemical in… | 2001 |
What descends from it? (8)
2 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?
- The line of descent spans 17 years and passes through 2 companies; a new generation was cleared every 11.0 years on median.
- 1 of the 4 ancestors has a recall of any class.
- Of its descendants, K102217 (STERIS Corporation, 2010) has gone furthest, with 5 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. 2008, this device’s year, is highlighted.
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 STERIS Resert XL Test Strip is a high level disinfectant concentration monitor
dedicated for use with Resento XL HLD High-Level Disinfectant. The purpose of the
STERIS Resert XL Test Strip is to determine whether the concentration of a Resert ® XL
HLD High-Level Disinfectant solution is above the minimum recommended
concentration (MRC) of 1.5%.
The STERIS Resert XL Test Strip only indicates hydrogen peroxide concentration and
does not confirm disinfection.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K081600 · printed Nov 6, 2026
Cite this page
510(k) Report. “K081600: Steris Resert XL Test Strip.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K081600
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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