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Steam Sterilization Intergrator

by Dana Products, Inc. 510(k)

Active United States

510(k) K012195

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK012195 Date7 May 2002ClearedStatusActive

Coverage

1 jurisdiction

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  • Withdrawn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

United States — FDA 510(k) Active

Recalls

0 recalls · FDA

No FDA recalls on record, checked 22 Oct 2026.

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, 21 Sep 2026

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

A Steam Sterilization Integrator is a physical/chemical indicator device used to monitor critical parameters in steam sterilization cycles. It responds to time and temperature when steam is present, with the endpoint determined by the migration of a steam-sensitive dye to a marked safe area on the indicator.

This device is intended for use in healthcare facilities and is supplied as a single-use indicator. It has received FDA 510(k) clearance under K012195, is classified as Class II, and is regulated under 21 CFR 880.2800. The product code is JOJ, and it is not a third-party reviewed device.

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Questions

AI-generated answers, 21 Sep 2026

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

  • What is the Steam Sterilization Integrator used for?

    It is a physical/chemical indicator device used to monitor critical parameters in steam sterilization cycles by responding to time and temperature when steam is present, with the endpoint determined by the migration of a steam-sensitive dye to a marked safe area on the indicator.

  • How is the Steam Sterilization Integrator supplied and is it reusable?

    The device is supplied as a single-use indicator, meaning it is intended for one-time use only and should be discarded after each sterilization cycle to ensure accurate monitoring.

  • What regulatory pathway was used for the Steam Sterilization Integrator?

    It received FDA 510(k) clearance under K012195, is classified as Class II, and is regulated under 21 CFR 880.2800 with product code JOJ, indicating it was found substantially equivalent to a legally marketed device.