Cleared Traditional

MICROSPIN 24 (K953519) - FDA 510(k) Clearance

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

K953519 · Vulcon Technologies · Hematology device
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Nov 1995
Decision
99d
Days
Class 2
Risk

K953519 is an FDA 510(k) clearance for the MICROSPIN 24. Classified as Instrument, Hematocrit, Automated (product code GKF), Class II - Special Controls.

Submitted by Vulcon Technologies (Grandview, US). The FDA issued a Cleared decision on November 3, 1995 after a review of 99 days - within the typical 510(k) review window.

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: 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 Vulcon Technologies devices

Submission Details

510(k) Number K953519 FDA.gov
FDA Decision Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received July 27, 1995
Decision Date November 03, 1995
Days to Decision 99 days
Submission Type Traditional
Review Panel Hematology (HE)
Summary Statement
Third-party Review No - reviewed directly by FDA
Regulatory Context
Review time vs. panel average
14d faster than avg
Panel avg: 113d · This submission: 99d
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 14
Devices cleared under the same product code (GKF) and FDA review panel - the closest regulatory comparables to K953519.
GEM Premier 5000 (Measured parameters: Hematocrit, Total Hemoglobin, Carboxyhemoglobin, Methemoglobin, Deoxyhemoglobin, Oxyhemoglobin, Oxygen Saturation)
K160415 · Instrumentation Laboratory CO · Dec 2016
SORVALL CAPSPIN MICROHEMATOCRIT CENTRIFUGE
K864646 · E.I. Dupont DE Nemours & Co., Inc. · Jan 1987
STAT-CRIT HEMATOCRIT MEASURING INSTRU
K802199 · United States Surgical, A Division of Tyco Healthc · Feb 1981