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Hermle Z230H

by Labnet Intl., Inc.

510(k) K920207

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 6 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 6 Oct 2026. What this means

Regulatory status

as of registry sync 6 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Traditional NumberK920207 Date9 Jun 1992ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 6 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  • Withdrawn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
GKG
Device Class
Class II
Regulation
21 CFR Part 864.6400
Advisory Committee
Hematology
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 19 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 Hermle Z230H is a hematology centrifuge. It is a device used for separating components of blood samples through centrifugal force.

It is supplied as a reusable device and has received FDA 510(k) clearance under product code GKG. The device is intended for use in laboratory settings and is not sterile or single-use.

Questions

AI-generated answers, 19 Sep 2026

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

  • Is the Hermle Z230H centrifuge designed for single-use or can it be reused in a clinical setting?

    The Hermle Z230H is explicitly described as a reusable device, meaning it is intended for repeated use in laboratory settings after proper cleaning and maintenance. It is not sterile or single-use, so it must be cleaned and disinfected between uses to ensure safety and accuracy in blood sample separation.

  • What types of blood samples is the Hermle Z230H centrifuge intended to process, and where would it typically be used?

    The Hermle Z230H is a hematology centrifuge, specifically designed to separate components of blood samples through centrifugal force. It is intended for use in laboratory settings, particularly in hematology workflows where precise separation of blood elements (e.g., plasma, serum, or cellular components) is required. Its regulatory filing under product code GKG and advisory committee HE (Hematology) further confirms its specialized role in blood analysis.

  • How is the Hermle Z230H centrifuge supplied, and what should be considered for its storage and maintenance?

    The Hermle Z230H is supplied as a reusable device, meaning it comes ready for immediate use in a lab environment. Since it is not sterile, it requires proper cleaning and disinfection between uses to maintain performance and prevent contamination. Storage should be in a clean, dry environment away from direct sunlight or extreme temperatures to preserve its functionality and ensure longevity. Regular maintenance, as outlined in the manufacturer’s instructions, is critical for accurate centrifugation.

  • What regulatory pathway was followed for the FDA clearance of the Hermle Z230H, and what does this imply for its use?

    The Hermle Z230H received FDA 510(k) clearance under the Traditional 510(k) pathway, with a decision classification of Substantially Equivalent (SESE) to a predicate device. This implies that the device was determined to have the same intended use and technological characteristics as a previously cleared centrifuge, ensuring it meets FDA safety and effectiveness standards for use in hematology laboratories. The clearance does not imply sterility or single-use but confirms its suitability for routine blood sample processing.