510(k) · Cleared
ClearedThe Reliance PI Process Indicator, Model D5116
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 Dec 21, 2004 after a 4-day review. The summary cites one number, which could not be confirmed as its predicate (see the table below). 8 later devices descend from it.
- Decided
- Dec 21, 2004
- Review
- 4 days
- Class
- Class II
- Product code
- JOJ
- Recalls
- None
- Predicates
- 1
8 later devices descend from it, 1 citing it directly.
- This deviceK043482 The Reliance PI Process Indicator, Model D5116STERIS Corporation · 2004
- Descendant · cites it directly · 7 of its ownK063285 Reliance CI Process IndicatorAlbert Browne, Ltd. · 2007
- Descendant · 2 generations on · 5 of its ownK102217 System 1E Chemical IndicatorSTERIS Corporation · 2010
- Descendant · 3 generations on · 3 of its ownK173428 VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018
- Descendant · 4 generations on · 1 of its ownK240032 Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024
- Descendant · 5 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- K063285Reliance CI Process IndicatorAlbert Browne, Ltd. · 2007 · cites it directly7descendants
- K102217System 1E Chemical IndicatorSTERIS Corporation · 2010 · 2 generations on5descendants
- K173428VERIFY Chemical Indicator for S40 SterilantSTERIS Corporation · 2018 · 3 generations on3descendants
- K240032Celerity Chemical Indicator for enspire 3000 CLCSPSSTERIS Corporation · 2024 · 4 generations on1descendant
- K243475Chemical Indicator for enspire CLCSPS (LCC015)STERIS Corporation · 2024 · 5 generations on0descendants
View FIG. 1 as a table
Line of descent and top descendants
| Generation | Number | Device | Applicant | Decided | Recalls |
|---|---|---|---|---|---|
| 0 (this device) | K043482 | The Reliance PI Process Indicator, Model D5116 | STERIS Corporation | 2004 | — |
| +1 | K063285 | Reliance CI Process Indicator | Albert Browne, Ltd. | 2007 | — |
| +2 | K102217 | System 1E Chemical Indicator | STERIS Corporation | 2010 | — |
| +3 | K173428 | VERIFY Chemical Indicator for S40 Sterilant | STERIS Corporation | 2018 | — |
| +4 | K240032 | Celerity Chemical Indicator for enspire 3000 CLCSPS | STERIS Corporation | 2024 | — |
| +5 | K243475 | Chemical Indicator for enspire CLCSPS (LCC015) | STERIS Corporation | 2024 | — |
Descendants by year cleared
| Year cleared | Devices | With a Class I recall |
|---|---|---|
| 2007 | 1 | 0 |
| 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; numbers the summary cites that cannot be its predicate are marked – and kept off the family tree.
| Type | Number | Device | Decided |
|---|---|---|---|
| Kept off the family tree | K921559 | STERIS PROCESS Chemical Monitor for the STERIS SYSTEM 1 Processing System Not in FDA’s 510(k), De Novo or PMA lists as we hold them (a misreading, a typo, or a number FDA does not list), so it is kept off the family tree Summary page 1…ical Process Indicator The Reliance Pl Process Indicator is substantially equivalent to the | STERIS PROCESS Chemical Monitor for the STERIS SYSTEM 1 Processing System (K921559) based on the following comparison: STERIS PROCESS Chemical Monitor (K921559) Reliance™ P| Property Process Indicator Intende… |
What descends from it? (8)
1 later device cites it directly; ranked here by how many devices descend from each in turn.
| Number | Device | Decided | Descendants |
|---|---|---|---|
| K063285 | Reliance CI Process Indicator | 2007 | 7 |
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, K063285 (Albert Browne, Ltd., 2007) has gone furthest, with 7 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 | — |
What is it indicated for?
The Reliance PI Process Indicator is a single use chemical indicator designed to change from the “START" dark pink color to the “ENDPOINT” orange color or lighter upon exposure to an effective dose of peracetic acid generated from Reliance™ DG Dry Germicide during the Reliance Endoscope Processing Cycle.
The Reliance Pl Process Indicator is intended to be used exclusively for the independent monitoring of the Reliance Endoscope Processing Cycle. The Reliance Pl Process Indicator is not an indicator of load disinfection or cleaning efficacy.
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/K043482 · printed Nov 5, 2026
Cite this page
510(k) Report. “K043482: The Reliance PI Process Indicator, Model D5116.” Lineage record from FDA 510(k) data and the FDA summary. Updated Nov 3, 2026. Accessed Nov 5, 2026. https://510kreport.com/device/K043482
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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