Cleared Traditional

K920207 - HERMLE Z230H

K920207 is an FDA 510(k) clearance for HERMLE Z230H, manufactured by Labnet Intl., Inc.. The device is a Class 2 Hematology device with product code GKG cleared through the Traditional 510(k) pathway after a 145-day FDA review.

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

FDA 510(k) Submission Details - K920207

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.

GKG Device Classification - Class 2, Special Controls

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 7
Devices cleared under the same product code (GKG) and FDA review panel - the closest regulatory comparables to K920207.
MULTI-CENTRIFUGE
K955795 · Novonx, Inc. · Mar 1996
MICROHEMATOCRIT ROTOR
K930415 · Fisher Scientific Co., LLC · Mar 1993
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