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Dana Reusable Testpack for Steam Sterilization for 10 Minute Extended Cycles

by Dana Products, Inc. 510(k)

Active United States

510(k) K103321

Regulatory status

as of 29 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK103321 Date16 Feb 2011ClearedStatusActive

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  • Withdrawn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
FRC
Device Class
Class II
Regulation
21 CFR Part 880.2800
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 23 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 a biological sterilization process indicator designed to monitor the effectiveness of steam sterilization cycles. It is used to verify that sterilization parameters have been met during extended 10-minute cycles.

The testpack is reusable and intended for use in general hospital settings. It is supplied non-sterile and must be cleaned and prepared according to manufacturer instructions prior to use. The device has received FDA 510(k) clearance under product code FRC and regulation number 880.2800.

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Questions

AI-generated answers, 23 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 DANA REUSABLE TESTPACK used for?

    It is a biological sterilization process indicator designed to monitor the effectiveness of steam sterilization cycles, specifically to verify that sterilization parameters have been met during extended 10-minute cycles in general hospital settings.

  • Is the DANA REUSABLE TESTPACK supplied sterile or non-sterile?

    The device is supplied non-sterile and must be cleaned and prepared according to the manufacturer's instructions prior to each use to ensure proper function during sterilization monitoring.

  • Can the DANA REUSABLE TESTPACK be reused, and what is required for reuse?

    Yes, the testpack is reusable; however, it must be cleaned and prepared according to the manufacturer's instructions before each use to maintain its effectiveness as a biological indicator for steam sterilization monitoring.

  • What regulatory clearance does the DANA REUSABLE TESTPACK have?

    The device has received FDA 510(k) clearance under product code FRC and regulation number 880.2800, confirming its status as substantially equivalent to a legally marketed predicate device.