Cleared Traditional

K925863 - SPUNCRIT

K925863 is the FDA 510(k) clearance for SPUNCRIT by bioMerieux, Inc.. It is a Class 2 Hematology device (product code GKG) cleared through the Traditional 510(k) pathway after a 78-day FDA review.

K925863 · bioMerieux, Inc. · Hematology device
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Feb 1993
Decision
78d
Days
Class 2
Risk

K925863 is an FDA 510(k) clearance for the SPUNCRIT. Classified as Centrifuge, Hematocrit (product code GKG), Class II - Special Controls.

Submitted by bioMerieux, Inc. (Bethlehem, US). The FDA issued a Cleared decision on February 5, 1993 after a review of 78 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 bioMerieux, Inc. devices

Submission Details

510(k) Number K925863 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 19, 1992
Decision Date February 05, 1993
Days to Decision 78 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Summary PDF
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
35d faster than avg
Panel avg: 113d · This submission: 78d
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

Devices cleared under the same product code (GKG) and FDA review panel - the closest regulatory comparables to K925863.
MICROHEMATOCRIT ROTOR
K930415 · Fisher Scientific Co., LLC · Mar 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