Cleared Traditional

K864646 - SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE

K864646 is the FDA 510(k) clearance for SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE by E.I. Dupont DE Nemours & Co., Inc.. It is a Class 2 Hematology device (product code GKF) cleared through the Traditional 510(k) pathway after a 41-day FDA review.

K864646 · E.I. Dupont DE Nemours & Co., Inc. · Hematology device
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Jan 1987
Decision
41d
Days
Class 2
Risk

K864646 is an FDA 510(k) clearance for the SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE. Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by E.I. Dupont DE Nemours & Co., Inc. (Newtown, US). The FDA issued a Cleared decision on January 5, 1987 after a review of 41 days - a notably fast clearance cycle.

This device falls under the Hematology FDA review panel, regulated under 21 CFR 864.5600 - 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 E.I. Dupont DE Nemours & Co., Inc. devices

Submission Details

510(k) Number K864646 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received November 25, 1986
Decision Date January 05, 1987
Days to Decision 41 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary -
Third-party Review No - reviewed directly by FDA
Combination Product No
PCCP Authorized No
Regulatory Context
Review time vs. panel average
72d faster than avg
Panel avg: 113d · This submission: 41d
Pathway characteristics
Predicate-based equivalence. No clinical trials required.

Device Classification

Product Code GKF Instrument, Hematocrit, Automated
Device Class Class 2 - Special Controls
CFR Regulation 21 CFR 864.5600
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 - GKF Instrument, Hematocrit, Automated

All 9
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K864646.
MARATHON 6K GENERAL-PURPOSE CENTRIFUGE
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K915441 · Fisher Scientific Co., LLC · Jan 1992
NEW COBE SATURATION/HEMATOCRIT MONITOR
K904336 · Cobe Laboratories, Inc. · Dec 1990
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199 · United States Surgical, A Division of Tyco Healthc · Feb 1981
CUTTER/COMPUR MINI CENTRIFUGE
K781059 · Cutter Laboratories, Inc. · Aug 1978