510(k) · Cleared
ClearedVERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Steris · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Dec 8, 2023 as substantially equivalent to K173428 (STERIS Corporation, 2018) after a 24-day review. Its family tree reaches back 5 generations to 1991.
- Decided
- Dec 8, 2023
- Review
- 24 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 5 generations to K910320 (1991). 9 ancestors in all. No later device cites it as a predicate yet.
- Root · 5 generations backK910320 Serim Peracetic Acid Reagent StripsSerim Research Corp. · 1991
- 4 generations backK972035 Sporox Test StripsSerim Research Corp. · 1997
- 3 generations backK081600 Steris Resert XL Test StripSTERIS Corporation · 2008
- 2 generations backK102217 System 1E Chemical IndicatorSTERIS Corporation · 2010
- 1 generation backK173428 VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018
- This deviceK233654 VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid…Steris · 2023
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −5 | K910320 | Serim Peracetic Acid Reagent Strips | Serim Research Corp. | 1991 | — |
| −4 | K972035 | Sporox Test Strips | Serim Research Corp. | 1997 | — |
| −3 | K081600 | Steris Resert XL Test Strip | STERIS Corporation | 2008 | — |
| −2 | K102217 | System 1E Chemical Indicator | STERIS Corporation | 2010 | — |
| −1 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018 | — |
| 0 (this device) | K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical… | Steris | 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 |
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 |
|---|---|---|---|
| * | K173428 | VERIFY Chemical Indicator for S40 SterilantSummary page 6…ss indicator Classification 21 CFR 880.2800 Product Code JOJ 2. Predicate Device VERIFY® Chemical Indicator for SYSTEM 1E Processor (K173428) 3. Device Description The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant P… | 2018 |
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?
- The line of descent spans 32 years and passes through 3 companies; a new generation was cleared every 6.3 years on median.
- 1 of the 9 ancestors has a recall of any class.
- 1 other device also cites its predicate K173428.
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. 2023, 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® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle. The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is blue. When exposed in a…
Read the full statement (133 words)
The VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is a peracetic acid concentration indicator for routine monitoring of SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems that employ S40 Sterilant Concentrate in a controlled cycle.
The unprocessed Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems is blue. When exposed in a STERIS automated liquid chemical sterilant processor to a concentration of >1820 ppm (mg/L) peracetic acid found in the S40 use dilution during a controlled 6-minute exposure at 45.5 — 60°C, 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 sterilant use dilution.
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/K233654 · printed Nov 6, 2026
Cite this page
510(k) Report. “K233654: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K233654
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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