Cleared Traditional

K864646 - SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE (FDA 510(k) Clearance)

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

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
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.