# K063285: Reliance CI Process Indicator

- Pathway: 510(k) (Traditional)
- Applicant: Albert Browne, Ltd.
- Decided: Jan 12, 2007 after 73 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
Longest line of descent: 1 generation back to K043482 (2004). 1 ancestor in all.
7 later devices descend from it; 2 cite 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)
- K043482: The Reliance PI Process Indicator, Model D5116, STERIS Corporation (2004) Summary page 2.

## Most influential descendants
- 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
- K233654: VERIFY® Chemical Indicator for SYSTEM 1E® and SYSTEM 1® endo Liquid Chemical Sterilant Processing Systems (2023), 0 descendants of its own

## Indications for use
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.

Source page: https://510kreport.com/device/K063285
Methodology: https://510kreport.com/methodology