510(k) · Cleared
ClearedSystem 1E Chemical Indicator
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 Nov 22, 2010 as substantially equivalent to K081600 (STERIS Corporation, 2008) and 1 other predicate after a 108-day review. Its family tree reaches back 3 generations to 1991. 5 later devices descend from it.
- Decided
- Nov 22, 2010
- Review
- 108 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 2
Its longest line of descent runs back 3 generations to K910320 (1991). 7 ancestors in all. 5 later devices descend from it, 2 citing it directly.
- Root · 3 generations backK910320 Serim Peracetic Acid Reagent StripsSerim Research Corp. · 1991
- 2 generations backK972035 Sporox Test StripsSerim Research Corp. · 1997
- 1 generation backK081600 Steris Resert XL Test StripSTERIS Corporation · 2008
- This deviceK102217 System 1E Chemical IndicatorSTERIS Corporation · 2010
- Descendant · cites it directly · 3 of its ownK173428 VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018
- Descendant · 2 generations on · 1 of its ownK240032 Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK243475 Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation · 2024
- Descendant · 2 generations on · 0 of its ownK233654 VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid…Steris · 2023
- Descendant · cites it directly · 0 of its ownK230558 Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation · 2023
Most influential descendants
Showing 5 of 5 · See all- K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018 · cites it directly3descendants
- K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024 · 2 generations on1descendant
- K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation · 2024 · 3 generations on0descendants
- K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant…Steris · 2023 · 2 generations on0descendants
- K230558Revital-Ox PAA High Level Disinfectant Chemical IndicatorSTERIS Corporation · 2023 · cites it directly0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −3 | K910320 | Serim Peracetic Acid Reagent Strips | Serim Research Corp. | 1991 | — |
| −2 | K972035 | Sporox Test Strips | Serim Research Corp. | 1997 | — |
| −1 | K081600 | Steris Resert XL Test Strip | STERIS Corporation | 2008 | — |
| 0 (this device) | K102217 | System 1E Chemical Indicator | STERIS Corporation | 2010 | — |
| +1 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018 | — |
| +2 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024 | — |
| +3 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024 | — |
| +2 | K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical… | Steris | 2023 | — |
| +1 | K230558 | Revital-Ox PAA High Level Disinfectant Chemical Indicator | STERIS Corporation | 2023 | — |
Other ancestors by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 1994 | 1 | 0 |
| 2001 | 1 | 0 |
| 2004 | 1 | 0 |
| 2007 | 1 | 0 |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 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 |
|---|---|---|---|
| * | K081600 | Steris Resert XL Test StripSummary page 2…indicator (21 CFR 880.2800 (b), Product Code JOJ) 2. Predicate Devices Verify Chemical Monitoring Strip for Resert Solutions (K08 1600) cleared as Resert XL Test Strip Reliance CI Process Indicator (K063285) 3. Device Description The V… | 2008 |
| * | K063285 | Reliance CI Process IndicatorSummary page 2…Predicate Devices Verify Chemical Monitoring Strip for Resert Solutions (K08 1600) cleared as Resert XL Test Strip Reliance CI Process Indicator (K063285) 3. Device Description The Verify® SYSTEM I E Chemical Indicator is a single-use chemical indicator consisti… | 2007 |
What descends from it? (5)
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 19 years and passes through 2 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 7 ancestors has a recall of any class.
- Of its descendants, K173428 (STERIS Corporation, 2018) has gone furthest, with 3 descendants of its own.
- 1 other device also cites its predicate K081600.
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. 2010, 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 Verify® SYSTEM 1E Chemical Indicator (SYSTEM IE Chemical Indicator) is a peracetic acid concentration indicator for routine monitoring of the SYSTEM I E Liquid Chemical Sterilant Processing System employing S40 Sterilant Concentrate. The unprocessed Verify® SYSTEM IE Chemical Indicator is blue. When exposed to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution, the indicator changes color from blue through an intermediate beige and then to the endpoint color pink. The indicator may become more pink when exposed to higher peracetic acid concentrations in S40 use dilution.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K102217 · printed Nov 6, 2026
Cite this page
510(k) Report. “K102217: System 1E Chemical Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K102217
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