# K043482: The Reliance PI Process Indicator, Model D5116

- Pathway: 510(k) (Traditional)
- Applicant: STERIS Corporation
- Decided: Dec 21, 2004 after 4 days
- Product code: JOJ (Indicator, Physical/Chemical Sterilization Process)
- Device class: 2
- Regulation: 21 CFR 880.2800
- Recalls of this device: none
- Data: FDA decisions to Oct 25, 2026; recalls to Oct 12, 2026

## Lineage
No predicates in its family tree.
8 later devices descend from it; 1 cites it directly.
0 of 9 devices in its family (counting itself) have a Class I recall.

## Predicates on the family tree (from the FDA summary)
- None. The summary cites one number, which could not be confirmed as its predicate (listed below).

## Cited in the summary but 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.

## Most influential descendants
- K063285: Reliance CI Process Indicator (2007), 7 descendants of its own
- K102217: System 1E Chemical Indicator (2010), 5 descendants of its own
- K173428: VERIFY Chemical Indicator for S40 Sterilant (2018), 3 descendants of its own
- K240032: Celerity Chemical Indicator for enspire 3000 CLCSPS (2024), 1 descendant of its own
- K243475: Chemical Indicator for enspire CLCSPS (LCC015) (2024), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K043482
Methodology: https://510kreport.com/methodology