Verify Process Indicator for Reliance EPS
510(k) K130160
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK130160 | Date16 Aug 2013 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 510(k) Number
- FDA product code
- JOJ
- Device class
- Class II
- Regulation
- 21 CFR Part 880.2800
- Advisory committee
- General Hospital
- FDA decision
- SESE Substantially Equivalent
Overview
AI-generated summary, 19 Sep 2026
The Verify Process Indicator for Reliance EPS is a single-use chemical indicator designed to monitor the effectiveness of the Reliance EPS Endoscope Processing System when using Reliance DG Dry Germicide. It visually confirms exposure to an effective dose of peracetic acid (PAA) by changing color from orange to white, ensuring proper sterilization or disinfection of endoscopes.
This indicator is supplied as a single-use strip in an airtight container with an integral desiccant sleeve, ensuring sterility and preventing moisture damage. It is intended for use in hospital or clinical settings where endoscope reprocessing occurs, with each indicator packaged in individual bottles that include a lot number and expiration date. The device holds an FDA 510(k) clearance under the General Hospital advisory committee classification and is classified as a Class II medical device.
Other devices from Steris Corporation
Questions
AI-generated answers, 19 Sep 2026
What is the Verify Process Indicator for Reliance EPS used for in endoscope reprocessing?
The Verify Process Indicator for Reliance EPS is a single-use chemical indicator designed to visually confirm whether endoscopes have been properly exposed to an effective dose of peracetic acid (PAA) during the disinfection or sterilization cycle in the Reliance EPS Endoscope Processing System. It changes color from orange to white to indicate successful exposure, ensuring the reprocessing process was effective.
How is the Verify Process Indicator packaged and stored to maintain sterility?
Each indicator is supplied in an individual airtight container that includes an integral desiccant sleeve to preserve sterility and prevent moisture damage. The packaging ensures the indicator remains uncontaminated until use, and each bottle is labeled with a lot number and expiration date for traceability.
Is the Verify Process Indicator for Reliance EPS intended for single-use or reuse?
The Verify Process Indicator is explicitly designed for single-use only. After one use to confirm the effectiveness of the reprocessing cycle, it should not be reused, as its chemical integrity and reliability would be compromised.
What regulatory pathway was followed for FDA clearance of this device?
The Verify Process Indicator for Reliance EPS received FDA clearance through a 510(k) submission, classified under the General Hospital advisory committee (HO) and categorized as a Class II medical device. The clearance was granted under the Traditional review pathway, with a decision date of August 16, 2013.
Are there multiple sizes or models of the Verify Process Indicator available?
The provided data does not specify variations in sizes or models for the Verify Process Indicator. It is supplied as a standardized single-use strip in individual airtight containers, with no indications of customizable or interchangeable versions.