Cleared Traditional

HERMLE Z230H (K920207) - FDA 510(k) Clearance

Class II Hematology device cleared through predicate-based substantial equivalence - typically does not require clinical trials.

K920207 · Labnet Intl., Inc. · Hematology device
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Jun 1992
Decision
145d
Days
Class 2
Risk

K920207 is an FDA 510(k) clearance for the HERMLE Z230H. Classified as Centrifuge, Hematocrit (product code GKG), Class II - Special Controls.

Submitted by Labnet Intl., Inc. (Woodbridge, US). The FDA issued a Cleared decision on June 9, 1992 after a review of 145 days - within the typical 510(k) review window.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.6400 - the FDA hematology device framework. The Traditional 510(k) pathway establishes clearance through substantial equivalence to a legally marketed predicate device, without requiring clinical trial data.

Device pattern: Standard predicate-based submission. Standard predicate reliance. This clearance follows a standard predicate-based equivalence path within the Hematology review framework, consistent with the majority of Class II 510(k) submissions.

View all Labnet Intl., Inc. devices

Submission Details

510(k) Number K920207 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 16, 1992
Decision Date June 09, 1992
Days to Decision 145 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
32d slower than avg
Panel avg: 113d · This submission: 145d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKG Centrifuge, Hematocrit
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.6400
What this classification means

Class II devices require demonstration of substantial equivalence to a legally marketed predicate device. This pathway does not require clinical trials - it relies on engineering equivalence and performance data. Most Hematology devices follow this clearance model.

Regulatory Peers - GKG Centrifuge, Hematocrit

All 10
Devices cleared under the same product code (GKG) and FDA review panel - the closest regulatory comparables to K920207.
SPUNCRIT
K925863 · bioMerieux, Inc. · Feb 1993
QBC CENTRIFUGAL HEMATOLOGY SYSTEM
K821803 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Sep 1982
HCT CENTRIFUGE
K822445 · Boehringer Mannheim Corp. · Sep 1982
CLAY ADAMS QBC CENTRIFUGAL HEMOTOLOGY
K813033 · Bd Becton Dickinson Vacutainer Systems Preanalytic · Apr 1982