510(k) · Cleared
ClearedReliance CI Process Indicator
Data to Oct 25, 2026 (FDA decisions) Oct 12, 2026 (recalls) Sep 30, 2026 (MAUDE) refreshed weekly
Albert Browne, Ltd. · JOJ Indicator, Physical/Chemical Sterilization Process
Cleared on Jan 12, 2007 as substantially equivalent to K043482 (STERIS Corporation, 2004) after a 73-day review. Its family tree reaches back 1 generation to 2004. 7 later devices descend from it.
- Decided
- Jan 12, 2007
- Review
- 73 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
Its longest line of descent runs back 1 generation to K043482 (2004). 7 later devices descend from it, 2 citing it directly.
- Root · 1 generation backK043482 The Reliance PI Process Indicator, Model D5116STERIS Corporation · 2004
- This deviceK063285 Reliance CI Process IndicatorAlbert Browne, Ltd. · 2007
- 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 · 4 generations on · 0 of its ownK243475 Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation · 2024
- Descendant · 3 generations on · 0 of its ownK233654 VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid…Steris · 2023
Showing 5 of 7 descendants. See all descendants
Descendants cleared per year
Most influential descendants
Showing 5 of 7 · 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
- K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation · 2024 · 4 generations on0descendants
- K233654VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant…Steris · 2023 · 3 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| −1 | K043482 | The Reliance PI Process Indicator, Model D5116 | STERIS Corporation | 2004 | — |
| 0 (this device) | K063285 | Reliance CI Process Indicator | Albert Browne, Ltd. | 2007 | — |
| +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 | — |
| +4 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024 | — |
| +3 | K233654 | VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical… | Steris | 2023 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2010 | 1 | 0 |
| 2013 | 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 |
|---|---|---|---|
| * | K043482 | The Reliance PI Process Indicator, Model D5116Summary page 2…hemical indicator Classification Name: Physical/chemical sterilization process indicator 3. PREDICATE DEVICE RelianceTM PI Process Indicator (K043482) 4. INTENDED USE The RelianceTM CI Process Indicator is intended for routine monitoring of the RelianceTM EPS E… | 2004 |
What descends from it? (7)
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?
- Its one ancestor has no recall.
- 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. 2007, 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 RelianceTM CI Process Indicator is intended for routine monitoring of the RelianceTM EPS Endoscope Processing System employing RelianceTM DG Dry Germicide. The RelianceTM CI Process Indicator is a peracetic acid dose indicator that changes color from orange to white (colorless) upon exposure to an effective dose of peracetic acid.
Indications for use as stated in the FDA summary.
https://510kreport.com/device/K063285 · printed Nov 6, 2026
Cite this page
510(k) Report. “K063285: Reliance CI Process Indicator.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 6, 2026. https://510kreport.com/device/K063285
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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