Cleared Traditional

K930415 - MICROHEMATOCRIT ROTOR

K930415 is an FDA 510(k) clearance for MICROHEMATOCRIT ROTOR, manufactured by Fisher Scientific Co., LLC. The device is a Class 2 Hematology device with product code GKG cleared through the Traditional 510(k) pathway after a 56-day FDA review.

K930415 · Fisher Scientific Co., LLC · Hematology device
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Mar 1993
Decision
56d
Days
Class 2
Risk

K930415 is an FDA 510(k) clearance for the MICROHEMATOCRIT ROTOR. Classified as Centrifuge, Hematocrit (product code GKG), Class II - Special Controls.

Submitted by Fisher Scientific Co., LLC (Pittsburgh, US). The FDA issued a Cleared decision on March 23, 1993 after a review of 56 days - a notably fast clearance cycle.

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: Fast-track predicate clearance. Standard predicate reliance. The short review cycle indicates strong predicate alignment - the FDA found sufficient equivalence without extended technical review.

View all Fisher Scientific Co., LLC devices

FDA 510(k) Submission Details - K930415

510(k) Number K930415 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received January 26, 1993
Decision Date March 23, 1993
Days to Decision 56 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
57d faster than avg
Panel avg: 113d · This submission: 56d
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

Devices cleared under the same product code (GKG) and FDA review panel - the closest regulatory comparables to K930415.
SPUNCRIT (MODEL DRC-40)
K961803 · Micro Diagnostics Corp. · Jul 1996
MULTI-CENTRIFUGE
K955795 · Novonx, Inc. · Mar 1996
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