Endpoint 500 Peracetic Acid Test Indicators

No FDA recalls found in the data synced 22 Oct 2026.

510(k) Number

K931935 ↗

FDA Product Code

JOJ

Device Class

Class II

Regulation

21 CFR Part 880.2800

Advisory Committee

General Hospital

FDA Decision

SESE Substantially Equivalent

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• What is the primary purpose of the Endpoint 500 Peracetic Acid Test Indicators?

  They are chemical indicator strips designed to monitor the concentration of peracetic acid during sterilization cycles, providing a visual readout that confirms the sanitizer is present at the calibrated parts‑per‑million levels.

• How are the test indicators supplied and intended to be used?

  The indicators are provided in various pack sizes and are intended for single‑use applications. Each strip is used once per sterilization run and then discarded, ensuring accurate, uncontaminated results for each test.

• Are the indicators sterile and can they be reused?

  The strips are not supplied sterile because they are meant to be exposed to the sterilization environment for testing. They are single‑use only and must not be reused, as reuse could compromise the calibrated response and lead to inaccurate readings.

• What regulatory classification applies to this device?

  The Endpoint 500 Peracetic Acid Test Indicators are classified as a Class II medical device and have received FDA 510(k) clearance (K931935) under product code JOJ, indicating they meet the required safety and performance standards for use in hospital settings.