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gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI)

by Gke-GmbH

510(k) K163144

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 · Traditional NumberK163144 Date7 Apr 2017ClearedStatusActive

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  • Withdrawn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
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.

The gke Steri-Record Steam Mini-Bio-Plus self-contained biological indicator (SCBI) is a biological indicator used to validate the effectiveness of steam sterilization processes. It is classified as a Class II medical device under regulation number 880.2800 and is identified by the product code FRC.

This device is supplied as a self-contained unit for use in general hospital settings. It is intended for single-use applications and is not MRI safe unless explicitly stated. Storage conditions and handling should follow manufacturer guidelines. The device received FDA 510(k) clearance under K163144 on April 7, 2017, and is substantially equivalent to a legally marketed predicate device.

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 gke Steri-Record Steam Mini-Bio-Plus used for?

    The gke Steri-Record Steam Mini-Bio-Plus is a biological indicator used to validate the effectiveness of steam sterilization processes. It is intended for use in general hospital settings to confirm that sterilization conditions have been met, ensuring the sterility of medical devices and instruments.

  • How is the gke Steri-Record Steam Mini-Bio-Plus supplied and is it reusable?

    The device is supplied as a self-contained unit and is intended for single-use applications only. It is not designed for reuse, as repeated use could compromise the accuracy of the biological indicator and lead to unreliable sterilization validation results.

  • What regulatory clearance does the gke Steri-Record Steam Mini-Bio-Plus have?

    The device received FDA 510(k) clearance under submission number K163144 on April 7, 2017. It was determined to be substantially equivalent to a legally marketed predicate device and is classified as a Class II medical device under regulation number 880.2800 with product code FRC.