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Canadian Technical Tape Ltd LF Process Indicator Steam Sterilization Tape

by Canadian Technical Tape, Ltd.

510(k) K161024

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 NumberK161024 Date28 Jun 2016ClearedStatusActive

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  • Withdrawn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, 26 Sep 2026

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

This device is an indicator, physical/chemical sterilization process, used to monitor steam sterilization conditions. It provides a visible change when adequate sterilization parameters have been met.

It is supplied as a tape for use in healthcare settings, specifically general hospitals. The device is a single-use indicator that received FDA 510(k) clearance under K161024 and is regulated under 21 CFR 880.2800.

Other devices from Canadian Technical Tape, Ltd.

Questions

AI-generated answers, 26 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 Canadian Technical Tape Ltd. LF Process Indicator Steam Sterilization Tape used for?

    This device is used to monitor steam sterilization conditions by providing a visible change when adequate sterilization parameters have been met, helping healthcare facilities verify that sterilization cycles have been effective.

  • Is the Canadian Technical Tape Ltd. LF Process Indicator Steam Sterilization Tape reusable or single-use?

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

  • How is the Canadian Technical Tape Ltd. LF Process Indicator Steam Sterilization Tape supplied and where is it typically used?

    It is supplied as a tape for use in healthcare settings, specifically general hospitals, where it is applied to packages or items before steam sterilization to visually indicate whether the process has reached the required conditions.