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VERIFY STEAM Integrating Indicator

by Steris Corporation 2 variants

510(k) K243876

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK243876 Date25 Apr 2025ClearedStatusActive

Recalls

0 recalls · FDA

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

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

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, 24 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The VERIFY STEAM Integrating Indicator is a Type 5 chemical indicator designed to monitor all critical parameters in steam sterilization cycle processes. It is a physical/chemical sterilization process indicator used to assess whether the necessary conditions for sterilization have been met.

Supplied in a 5CM pouch format (500 units), the device is intended for use in general hospital settings. It is a single-use indicator that provides a visual readout to confirm exposure to saturated steam under specified time and temperature conditions, supporting infection control practices in healthcare facilities.

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