Cleared Traditional

MULTI-CENTRIFUGE (K955795) - FDA 510(k) Clearance

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

K955795 · Novonx, Inc. · Hematology device
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Mar 1996
Decision
98d
Days
Class 2
Risk

K955795 is an FDA 510(k) clearance for the MULTI-CENTRIFUGE. Classified as Centrifuge, Hematocrit (product code GKG), Class II - Special Controls.

Submitted by Novonx, Inc. (Salt Lake City, US). The FDA issued a Cleared decision on March 29, 1996 after a review of 98 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 Novonx, Inc. devices

Submission Details

510(k) Number K955795 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received December 22, 1995
Decision Date March 29, 1996
Days to Decision 98 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
15d faster than avg
Panel avg: 113d · This submission: 98d
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 K955795.
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