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Reliance CI Process Indicator

FDA 510(k)

Class II (US FDA 510(k))

510(k) K063285

by Albert Browne , Ltd.

Identifiers

510(k) Number
K063285 FDA 510(k)
FDA Product Code
JOJ FDA 510(k)

Classification

Device Class
Class II FDA 510(k)
Legislation / Framework
21 CFR Part 880.2800 FDA 510(k)
Regulation Number
880.2800 FDA 510(k)
Advisory Committee
General Hospital FDA 510(k)
FDA Decision
SESE Substantially Equivalent FDA 510(k)

The Reliance CI Process Indicator is a single-use chemical indicator designed to monitor the peracetic acid (PAA) dose during endoscope processing. It visually confirms the completion of the sterilization cycle in a physical/chemical sterilization process, ensuring proper exposure to the sterilant at the point of use.

This indicator is supplied as a single-use device, featuring printed indicator ink on one end. It is intended for use within the Reliance EPS Endoscope Processing System and is not reusable. The device is classified under FDA’s Class II regulatory category and holds a 510(k) clearance (K063285). No additional sterility or MRI safety information is specified in the provided data.

Frequently asked questions

What is the Reliance CI Process Indicator used for?

The Reliance CI Process Indicator is a single-use chemical indicator designed to monitor the peracetic acid (PAA) dose during endoscope processing. It visually confirms whether the sterilization cycle has been completed properly by ensuring the endoscope has been adequately exposed to the sterilant at the point of use. This helps prevent under- or over-processing, ensuring safe and effective sterilization.

How is the Reliance CI Process Indicator supplied and used?

The indicator is supplied as a single-use device featuring printed indicator ink on one end. It is intended exclusively for use within the Reliance EPS Endoscope Processing System. After placement in the system, the indicator changes visually to confirm successful sterilization exposure to PAA. It is not reusable and must be discarded after each use.

Is the Reliance CI Process Indicator sterile?

The provided data does not specify any sterility information for the Reliance CI Process Indicator. However, since it is a single-use chemical indicator for sterilization monitoring, it is typically designed to be non-sterile itself, as its purpose is to verify the sterilization process rather than to be sterile. Always follow manufacturer guidelines for proper handling and use.

Can the Reliance CI Process Indicator be reused?

No, the Reliance CI Process Indicator is explicitly designed as a single-use device. Reusing it could compromise its accuracy and reliability in confirming proper sterilization exposure. Each indicator should be used once and then discarded to ensure correct monitoring of the PAA sterilization cycle.

What regulatory approval does the Reliance CI Process Indicator hold?

The Reliance CI Process Indicator holds FDA 510(k) clearance under the classification of Class II medical devices. The clearance number is K063285, and it was determined to be substantially equivalent to a predicate device. This approval indicates that the device meets FDA requirements for safety and effectiveness as a chemical indicator for PAA sterilization monitoring.

This description and any FAQs above were generated automatically from registry data and have not been verified by the manufacturer or by deviCERTS. Always check the official registry entry and the manufacturer's instructions for use before relying on them. Sources consulted: RELIANCE CI PROCESS INDICATOR (K063285) — FDA 510(k) | Innolitics, PDF JAN .1 2 4007 - Food and Drug Administration, PDF K063285 - Reliance Ci Process Indicator, RELIANCE CI PROCESS INDICATOR 510 (k) K063285 - FDA.report

Authorization Coverage (1 country)

Regulatory Authorizations

United States Active

FDA_510K

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Manufacturer

Manufacturer
Albert Browne , Ltd.

Sources (1)

  • FDA 510(k) K063285 24 fields · synced Oct 1, 2026